evt_NCT05415215_v29_v30_d1ea363dbff7

{
  "changed_paths": [
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/resultsFirstSubmitDate",
    "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/6/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/7/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/7/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/8/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/8/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/8/reviewUnit",
    "/protocolSection/outcomesModule/secondaryOutcomes/9/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/9/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/9/reviewUnit",
    "/protocolSection/outcomesModule/secondaryOutcomes/10/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/10/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/10/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/10/reviewUnit",
    "/protocolSection/outcomesModule/secondaryOutcomes/11/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/11/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/11/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/12/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/12/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/12/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/13/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/13/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/13/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/14/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/14/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/14/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/15/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/15/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/15/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/16/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/16/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/16/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/17/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/17/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/17/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/18/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/18/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/18/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/19/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/19/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/19/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/20/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/20/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/20/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/21/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/21/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/21/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/22/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/22/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/22/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/23/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/23/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/23/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/24/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/24/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/24/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/25/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/25/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/25/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/26/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/26/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/26/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/27",
    "/hasResults",
    "/resultsSection",
    "/annotationSection",
    "/documentSection"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT05415215_v29_v30_d1ea363dbff7. ClinicalTrials.gov NCT05415215, versions 29-30. Evidence version 1.",
  "claims_not_supported": [
    "That the amendment was scientifically unjustified.",
    "That the change constitutes misconduct or wrongdoing.",
    "That sponsor intent can be inferred from this registry change.",
    "That the change caused or altered the trial's results.",
    "That the change was or was not disclosed in a manuscript.",
    "That TrialDiff determines regulatory compliance or non-compliance.",
    "That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.",
    "That event-class membership is a validated global review-priority ranking."
  ],
  "claims_supported": [
    "TrialDiff compared ClinicalTrials.gov record version 29 to version 30 for NCT05415215.",
    "The JSON Patch for this comparison has hash 457eec6841ec266c36f1335b88efd132460052da78d0bfe3f745100c4797393c.",
    "The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
    "The deterministic triage label was low; before timing adjustment it was low.",
    "The triage label is uncalibrated metadata, not a validated review-priority finding.",
    "The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting, secondary_outcome_removed_after_primary_completion.",
    "The timing context for the from-version record was post_recruitment.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /protocolSection/outcomesModule/secondaryOutcomes/4/measure, /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/5/measure, /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/5/description, /protocolSection/outcomesModule/secondaryOutcomes/6/measure, /protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/6/description, /protocolSection/outcomesModule/secondaryOutcomes/7/measure, /protocolSection/outcomesModule/secondaryOutcomes/7/description, /protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/8/measure, /protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/8/description, /protocolSection/outcomesModule/secondaryOutcomes/8/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/9/measure, /protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/9/description, /protocolSection/outcomesModule/secondaryOutcomes/9/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/10/measure, /protocolSection/outcomesModule/secondaryOutcomes/10/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/10/description, /protocolSection/outcomesModule/secondaryOutcomes/10/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/11/measure, /protocolSection/outcomesModule/secondaryOutcomes/11/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/11/description, /protocolSection/outcomesModule/secondaryOutcomes/12/measure, /protocolSection/outcomesModule/secondaryOutcomes/12/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/12/description, /protocolSection/outcomesModule/secondaryOutcomes/13/measure, /protocolSection/outcomesModule/secondaryOutcomes/13/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/13/description, /protocolSection/outcomesModule/secondaryOutcomes/14/measure, /protocolSection/outcomesModule/secondaryOutcomes/14/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/14/description, /protocolSection/outcomesModule/secondaryOutcomes/15/measure, /protocolSection/outcomesModule/secondaryOutcomes/15/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/15/description, /protocolSection/outcomesModule/secondaryOutcomes/16/measure, /protocolSection/outcomesModule/secondaryOutcomes/16/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/16/description, /protocolSection/outcomesModule/secondaryOutcomes/17/measure, /protocolSection/outcomesModule/secondaryOutcomes/17/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/17/description, /protocolSection/outcomesModule/secondaryOutcomes/18/measure, /protocolSection/outcomesModule/secondaryOutcomes/18/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/18/description, /protocolSection/outcomesModule/secondaryOutcomes/19/measure, /protocolSection/outcomesModule/secondaryOutcomes/19/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/19/description, /protocolSection/outcomesModule/secondaryOutcomes/20/measure, /protocolSection/outcomesModule/secondaryOutcomes/20/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/20/description, /protocolSection/outcomesModule/secondaryOutcomes/21/measure, /protocolSection/outcomesModule/secondaryOutcomes/21/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/21/description, /protocolSection/outcomesModule/secondaryOutcomes/22/measure, /protocolSection/outcomesModule/secondaryOutcomes/22/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/22/description, /protocolSection/outcomesModule/secondaryOutcomes/23/measure, /protocolSection/outcomesModule/secondaryOutcomes/23/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/23/description, /protocolSection/outcomesModule/secondaryOutcomes/24/measure, /protocolSection/outcomesModule/secondaryOutcomes/24/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/24/description, /protocolSection/outcomesModule/secondaryOutcomes/25/measure, /protocolSection/outcomesModule/secondaryOutcomes/25/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/25/description, /protocolSection/outcomesModule/secondaryOutcomes/26/measure, /protocolSection/outcomesModule/secondaryOutcomes/26/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/26/description, /protocolSection/outcomesModule/secondaryOutcomes/27, /hasResults, /resultsSection, /annotationSection, /documentSection.",
    "An outcome path changed between versions 29 and 30 in a patch that also carried a hasResults or resultsSection co-occurrence signal.",
    "The JSON Patch removed a whole secondary outcome item after primary completion between versions 29 and 30; when a TO-version outcome list is available, reindex-only removals are excluded."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "results_reconciliation"
    ],
    "category": "results_reconciliation",
    "deterministic_rules": [],
    "event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting",
      "secondary_outcome_removed_after_primary_completion"
    ],
    "rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
    "severity": "low",
    "severity_pre_timing": "low",
    "timing_context": "post_recruitment",
    "triage_label": "low",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/primaryOutcomes/0/description",
          "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
          "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/10/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/10/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/10/reviewUnit",
          "/protocolSection/outcomesModule/secondaryOutcomes/10/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/11/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/11/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/11/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/12/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/12/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/12/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/13/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/13/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/13/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/14/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/14/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/14/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/15/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/15/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/15/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/16/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/16/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/16/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/17/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/17/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/17/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/18/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/18/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/18/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/19/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/19/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/19/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/20/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/20/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/20/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/21/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/21/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/21/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/22/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/22/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/22/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/23/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/23/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/23/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/24/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/24/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/24/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/25/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/25/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/25/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/26/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/26/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/26/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/27",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/6/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/7/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/7/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/8/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/8/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/8/reviewUnit",
          "/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/9/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/9/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/9/reviewUnit",
          "/protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT05415215_v29_v30_d1ea363dbff7",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2025-11-19"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2025-12-04"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitDate",
      "value": "2025-11-19"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "value": "Cross-over Period: Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in Question 1 of the Patient Preference Questionnaire (PPQ)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "value": "Upon completion of adjuvant cross-over period (Day 1 of Cycle 8 or 9; Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "value": "The PPQ was used to evaluate the participant preference for PH FDC SC compared to P+H IV.\nParticipants completed the PPQ, where Question (Q) 1 was: "All things considered, which setting for your treatment did you prefer?"\nParticipants were required to select one of the following options: home, hospital or no preference.\nThe reported results show the percentage of participants who preferred receiving PH FDC SC at home setting over the hospital setting.\nPercentages were rounded off."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
      "value": "Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
      "value": "Day 1 of Cycles 1-8 (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
      "value": "HCP was defined as any personnel involved in the drug preparation and/or drug administration processes.\nHCPs who have had experience with preparation of P+H IV and/or administration of PH FDC SC completed the following question of the HCPQ: Q1a: "Please indicate which treatment preparation the estimates relate to".\nHCPs were required to select one of the following options: PH FDC SC or P+H IV.\nThe response to Q1a was used to further assess Q1b: How long did it take to prepare the treatment for use?\nPercentages were rounded off."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
      "value": "Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
      "value": "Day 1 of Cycles 1-8 (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
      "value": "HCP was defined as any personnel involved in the drug preparation and/or drug administration processes.\nHCPs who have had experience with preparation of P+H IV and/or administration of PH FDC SC completed the following question of the HCPQ: Q1b: "How long did it take to prepare the treatment for use?"\nThis was a follow up question to Q1a: "Please indicate which treatment preparation the estimates relate to" for which HCPs were required to select one of the following options: PH FDC SC or P+H IV."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
      "value": "Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
      "value": "Up to Day 1 of Cycle 8 (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
      "value": "HCP=any personnel involved in the drug preparation and/or drug administration processes.\nHCPs who have had experience with preparation of P+H IV and/or administration of PH FDC SC completed the following question 2 of the HCPQs: In your opinion, if all P+H IV infusions were switched to PH FDC SC injections, please indicate how strongly you agree/disagree with each of the following statements.\n2a: Staff will have increased availability for other tasks in the pharmacy.\n2b: Administrative procedures related to PH FDC SC require less time.\n2c: Using PH FDC SC provides more flexibility for pharmacy staff in managing their workload.\n2d: As PH FDC SC is fixed-dose, potential dosing errors are avoided.\n2e: As PH FDC SC is fixed-dose, there is less drug wastage.\n2f: Less storage space for PH FDC SC-related supplies is required in the pharmacy, as there is no need for reconstitution.\n2g: Number of preparation steps & staff time commitment are reduced.\nPercentages were rounded off."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
      "value": "Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
      "value": "Day 1 of Cycles 1-8 (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
      "value": "<p>HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with administration of P+H IV and&#x2F;or PH FDC SC completed the following Questions of the HCPQ: Q1a: Please indicate which treatment preparation the estimates relate to.\nQ1b: Did the participant have existing IV access?\nQ1c: If new IV access was needed for this cycle of treatment, please indicate what type of IV access was provided.\nQ1d: What type of existing IV access did the participant have?\nQ1e: When did the existing IV access place?\nPercentages were rounded off.</p><p>PICC = peripherally inserted central catheter.</p>"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
      "value": "Neoadjuvant Phase: Duration of Treatment Administration According to HCPs&#x27; Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
      "value": "Day 1 of Cycles 1-8 (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
      "value": "HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with administration of P+H IV and&#x2F;or PH FDC SC completed the following Questions of the HCPQ: Q1c: If new IV access was needed for this cycle of treatment, how long (in minutes) this took to set up? Q1f: How long (in minutes) did it take to administer the treatment (P+H IV or PH FDC SC)? Q1g: How long (in minutes) was the participant in the Treatment Area in total?\nPercentages have been rounded off."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
      "value": "Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
      "value": "Up to Cycle 8 (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
      "value": "HCP was defined as any personnel involved in the drug preparation &amp;&#x2F;or drug administration processes.\nHCPs who have had experience with administration of P+H IV &amp;&#x2F;or PH FDC SC completed Q2 (2a-2e) of the HCPQ: In your opinion, if all P+H IV infusions were switched to PH FDC SC injections, please indicate how strongly you agree&#x2F;disagree with each of the following statements.\n2a: Participants may be moved out of the Treatment Area (for infusion treatment) to receive PH FDC SC injections.\n2b: PH FDC SC&#x27;s SC route of administration allows for more flexible treatment scheduling.\n2c: Frees up infusion chairs for participants whose treatments can only be given IV.\n2d: Waiting list for any P+H IV treatment at the Treatment Area is reduced.\n2e: Staff&#x27;s work burden is reduced, enhancing work performance.\nThe 6 available options were: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree and Not applicable.\nPercentages were rounded off."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
      "value": "Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
      "value": "Up to Cycle 8 (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/6/description",
      "value": "HCP was defined as any personnel involved in the drug preparation &amp;&#x2F;or drug administration processes.\nHCPs who have had experience with administration of P+H IV &amp;&#x2F;or PH FDC SC completed Question 2 (2f to 2j) of the HCPQ: In your opinion, if all P+H IV infusions were switched to PH FDC SC injections, please indicate how strongly you agree&#x2F;disagree with each of the following statements.\n2f: More interaction time between HCPs and participants.\n2g: Staff have more time for further professional education&#x2F;development.\n2h: Staff has more time for administrative tasks.\n2i: Participants on PH FDC SC spend less time in the Treatment Area.\n2j: Participants prefer PH FDC SC to P+H IV.\nThe 6 available options were: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree and Not applicable.\nPercentages were rounded off."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/7/measure",
      "value": "Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/7/description",
      "value": "HCPs who have had experience with administration of P+H IV &amp;&#x2F;or PH FDC SC completed Questions 3 to 11 of the HCPQ: Q3: Which was more convenient for the participant?\nQ4: Which was better for optimising participant care at your institution?\nQ5: Which required less time to administer (excluding observation period)?\nQ6: Which required less use of institutional resources (e.g., staff time, facility costs, equipment use)?\nQ7: Which required less time to administer all the treatment (including IV chemotherapy)?\nQ8: Which allowed for attending to more participants because of time savings from the mode of administration of pertuzumab and trastuzumab?\nQ9: During the NP you had to administer IV chemotherapy through participant&#x27;s IV access.\nYou prefer to accompany IV chemotherapy with?\nQ10: Which was preferred by participants?\nQ11: How frequently would you recommend PH FDC SC administration to your participants in the future?\nPercentages were rounded off."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame",
      "value": "Up to Cycle 8 (Cycle length = 21 days)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/8/measure",
      "value": "Percentage of Participants Who Achieved pCR Post-surgery"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame",
      "value": "Up to approximately 28 months"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/8/description",
      "value": "pCR was defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0&#x2F;Tis ypN0), according to the current American Joint Committee on Cancer (AJCC) staging system classification.\nPercentages were rounded off."
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/8/reviewUnit",
      "value": {
        "resetReasons": [
          "The Time Frame appears inconsistent with information provided here or in other parts of the record."
        ]
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/9/measure",
      "value": "Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame",
      "value": "Baseline, Day 1 of Cycles 6 and 8 (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/9/description",
      "value": "EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions used to assess the HRQoL in cancer participants.\nFirst 28 questions evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).\nThese questions used a 4-point scale, with scores ranging from 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much).\nThe last 2 questions represented the participant&#x27;s assessment of global health status (GHS) and quality of life (QoL), using a 7-point scale with scores ranging from 0-7 (1=very poor to 7=excellent).\nEORTC QLQ-C30 scores were linearly transformed on a scale of 0 - 100, with a high score indicating better GHS&#x2F;QOL.\nNegative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement."
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/9/reviewUnit",
      "value": {
        "resetReasons": [
          "The description of the scale or categories does not include sufficient information to understand the results reported."
        ]
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/10/measure",
      "value": "Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/10/timeFrame",
      "value": "Baseline (Cycle 1) of Run-in Period; Day 1 of Cycles 1, 3, and 6 in the Cross-over Period (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/10/description",
      "value": "EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions used to assess the HRQoL in cancer participants.\nFirst 28 questions evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).\nThese questions used a 4-point scale, with scores ranging from 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much).\nThe last 2 questions represented the participant&#x27;s assessment of GHS&#x2F;QoL, using a 7-point scale with scores ranging from 0-7 (1=very poor to 7=excellent).\nEORTC QLQ-C30 scores were linearly transformed on a scale of 0 - 100, with a high score indicating better GHS&#x2F;QOL.\nNegative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement."
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/10/reviewUnit",
      "value": {
        "resetReasons": [
          "The description of the scale or categories does not include sufficient information to understand the results reported."
        ]
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/11/measure",
      "value": "Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/11/timeFrame",
      "value": "Day 1 of Cycles 3 and 6 (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/11/description",
      "value": "HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with preparation and&#x2F;or administration of PH FDC SC completed the following questions of the HCPQ: Q1a: Where was the treatment prepared?\nQ1c: Which healthcare professionals were involved in the treatment preparation processes?\nThe 4 available response options for Q1a were: Participant&#x27;s home, Hospital pharmacy, Day oncology unit, or Other.\nThe 5 available response options for Q1c were: Physician, Nurse, Pharmacist, All of them or Other.\nPercentages were rounded off."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/12/measure",
      "value": "Adjuvant Cross-over Period: Duration of Treatment Preparation, According to HCPs&#x27; Responses to Question 1b of the HCPQ - Drug Preparation Area"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/12/timeFrame",
      "value": "Day 1 of Cycles 3 and 6 (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/12/description",
      "value": "HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with preparation and&#x2F;or administration of PH FDC SC completed the following parts of question Q1b: Q1b(1): How long did it take to prepare the treatment for use?\nQ1b(2): Time from the preparation place to reach the participant&#x27;s home."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/13/measure",
      "value": "Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/13/timeFrame",
      "value": "Day 1 of Cycle 6 (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/13/description",
      "value": "HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with preparation and&#x2F;or administration of PH FDC SC completed the questions 2, 3 and 4 of the HCPQ: Q2: If all PH FDC SC injections were switched from an in-hospital setting to the participant´s home, please indicate how strongly you agree or disagree with each of the following statements: 2a: Staff will have increased availability for other tasks in the hospital´s pharmacy.\n2b: Administrative procedures related to PH FDC SC will require less time.\n2c: Number of preparation steps and staff time commitment are reduced.\nThe 5 response options were: Strongly disagree, Disagree, Neutral, Agree, Strongly agree or Not applicable.\nQ3: Which took less time?\nQ4: Which required less use of institutional resources?\nThe 4 available options were: Participant&#x27;s home, In hospital, No difference, or Unsure.\nPercentages were rounded off."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/14/measure",
      "value": "Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs&#x27; Responses to Question 1a to 1f of the HCPQ - Administering Treatment"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/14/timeFrame",
      "value": "Day 1 of Cycles 3 and 6 (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/14/description",
      "value": "HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with the preparation and&#x2F;or administration of PH FDC SC completed the following questions of the HCPQ: Q1a: How long did it take to travel to the participant&#x27;s home to administer PH FDC SC? Q1b: How long did it take for the participant to travel to the hospital to receive PH FDC SC? Q1c: How long did it take to administer PH FDC SC? Q1d: How long was the participant treatment time?\nQ1e: How much time did the participant spend in hospital?\nQ1f: How much time did you spend at the participant&#x27;s home?\nFrom arrival to departure time."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/15/measure",
      "value": "Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/15/timeFrame",
      "value": "Day 1 of Cycles 3 and 6 (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/15/description",
      "value": "HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with the preparation and&#x2F;or administration of PH FDC SC completed the following questions of the HCPQ: Q1g.\nDoes the participant still have implanted IV access?\nThe 2 available responses were: Yes or No. Q1h: If question 1g was answered &#x27;No&#x27;, when was the IV access removed?\nThe 3 available responses were: After surgery and before initiating adjuvant treatment; After initiating adjuvant treatment, or Not applicable.\nQ1i: If question 1g was answered &#x27;Yes&#x27;, what is the main reason to keep the IV access?\nThe 5 available responses were: Local protocol; Risk of recurrence; Participant preference; Not applicable, or Other.\nPercentages were rounded off."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/16/measure",
      "value": "Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/16/timeFrame",
      "value": "Day 1 of Cycle 6 (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/16/description",
      "value": "HCPs who have had experience with the preparation and&#x2F;or administration of PH FDC SC completed the following questions of the HCPQ: Q1j: How long do you keep implanted IV access in early human epidermal growth factor receptor 2 (HER2)-positive breast cancer participants with pCR following surgery in your institution?\nThe 5 available responses were: &lt;12 months, ≥12 months, 18 months, &lt;24 months, ≥24 months.\nQ1k: When is the decision point for you to decide to remove IV access for early HER2+ breast cancer participants?\nThe 6 available responses were: Before surgery, After surgery, After PCR results, After completion of full adjuvant therapy, After completion of IV antineoplastic within adjuvant therapy, and Other.\nQ1l: Do you consider it necessary to keep implanted IV access knowing that the participant&#x27;s treatment will be SC until the full 18 cycles?\nThe 3 available responses were: Yes, No, and Other.\nPercentages were rounded off."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/17/measure",
      "value": "Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/17/timeFrame",
      "value": "Day 1 of Cycle 6 (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/17/description",
      "value": "HCPs who have had experience with the preparation and&#x2F;or administration of PH FDC SC completed the following question of the HCPQ: Q2: If all PH FDC SC injections were switched from an in-hospital setting to the participant&#x27;s home, please indicate how strongly you agree&#x2F;disagree with each of the following statements: 2a: PH FDC SC&#x27;s SC route of administration allows for more flexible treatment scheduling.\n2b: Frees up infusion chairs or outpatient procedure rooms used to administer SC injections.\n2c: Waiting list for infusion chairs or outpatient procedure rooms is reduced.\n2d: Staff&#x27;s work burden is reduced, enhancing work performance.\n2e: More interaction time between HCPs and participants on IV treatment.\n2f: Staff has more time for administrative tasks.\n2g: Participants will spend less time in hospital.\n2h: Participants prefer PH FDC SC at home.\nThe 6 available responses were: Strongly disagree, Disagree, Neutral, Agree, Strongly agree, &amp; Not applicable."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/18/measure",
      "value": "Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/18/timeFrame",
      "value": "Day 1 of Cycle 6 (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/18/description",
      "value": "HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with the preparation and&#x2F;or administration of PH FDC SC completed the following questions of the HCPQ: Q3: Which was more convenient for the participant?\nQ4: Which was better for optimising participant care?\nQ5: Which required less use of institutional resources?\nQ6: Which was preferred by participants?\nThe 4 responses available were: Participant&#x27;s home, In hospital, No difference, and Unsure.\nQ7: How frequently would you recommend PH FDC SC at home to your participants in the future?\nThe 3 responses available were: Always, Sometimes, and Never.\nPercentages were rounded off."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/19/measure",
      "value": "Adjuvant Phase: HRQoL Assessed by EORTC QLQ C30 Scores in Participants Treated With Trastuzumab Emtansine IV"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/19/timeFrame",
      "value": "Day 1 of Cycles 1 and 6 (1 Cycle = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/19/description",
      "value": "EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions used to assess the HRQoL in cancer participants.\nFirst 28 questions evaluates 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).\nThese questions used a 4-point scale, with scores ranging from 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much).\nThe last 2 questions represents the participant&#x27;s assessment of GHS&#x2F;QoL, using a 7-point scale with scores ranging from 0-7 (1=very poor to 7=excellent).\nEORTC QLQ-C30 scores will be linearly transformed on a scale of 0 - 100, with a high score indicating better GHS&#x2F;QOL.\nNegative change from Baseline values indicates deterioration in QOL or functioning and positive values indicates improvement."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/20/measure",
      "value": "Percentage of Participants Who Selected the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in the Treatment Continuation Period"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/20/timeFrame",
      "value": "Upon completion of adjuvant cross-over period (Day 1 of Cycle 8 or 9; Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/20/description",
      "value": "The percentage of participants who chose to receive PH FDC SC in the home setting or in the hospital setting during the treatment continuation period is reported."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/21/measure",
      "value": "Neoadjuvant Phase: Number of Participants With Adverse Events (AEs), Grade ≥ 3 AEs, Serious AEs (SAEs), and Cardiac AEs"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/21/timeFrame",
      "value": "From initiation of study treatment until 28 days after the last treatment cycle (up to approximately 7.4 months)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/21/description",
      "value": "AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with use of a study treatment, whether or not considered related to the study treatment.\nSAE=any untoward medical occurrence that, at any dose: Results in death; Is life threatening; Requires inpatient hospitalization&#x2F;prolongation of existing hospitalization; Results in persistent disability&#x2F;incapacity &amp;&#x2F;or is a congenital anomaly&#x2F;birth defect.\nCardiac AEs=asymptomatic decline in left ventricular ejection fraction (LVEF) of ≥10% from baseline to an LVEF &lt;50%; asymptomatic decline in LVEF requiring treatment&#x2F;leading to discontinuation of study treatment; congestive heart failure (CHF).\nAEs ≥Grade 3=marked limitation of physical activity.\nComfortable at rest, but any ordinary activity causes fatigue, palpitation&#x2F;dyspnea; Inability to carry any physical activity without discomfort.\nSymptoms of cardiac insufficiency at rest.\nAny physical activity leads to discomfort."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/22/measure",
      "value": "Neoadjuvant Phase: Number of Participants With Premature Withdrawal From PH FDC SC and P+H IV Due to AEs"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/22/timeFrame",
      "value": "Up to Cycle 8 (1 Cycle = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/22/description",
      "value": "An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment.\nAn AE can therefore be any unfavorable &amp; unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study intervention.\nParticipants who discontinued the study due to AEs are reported here."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/23/measure",
      "value": "Adjuvant Cross-over Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/23/timeFrame",
      "value": "From initiation of study treatment until 28 days after the last treatment cycle (up to approximately 5.8 months)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/23/description",
      "value": "AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with use of a study treatment, whether or not considered related to the study treatment.\nSAE=any untoward medical occurrence that, at any dose: Results in death; Is life threatening; Requires inpatient hospitalization&#x2F;prolongation of existing hospitalization; Results in persistent disability&#x2F;incapacity &amp;&#x2F;or is a congenital anomaly&#x2F;birth defect.\nCardiac AEs=asymptomatic decline in LVEF of ≥10% from baseline to an LVEF &lt;50%; asymptomatic decline in LVEF requiring treatment&#x2F;leading to discontinuation of study treatment; CHF.\nAEs ≥Grade 3=marked limitation of physical activity.\nComfortable at rest, but any ordinary activity causes fatigue, palpitation&#x2F;dyspnea; Inability to carry any physical activity without discomfort.\nSymptoms of cardiac insufficiency at rest.\nAny physical activity leads to discomfort."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/24/measure",
      "value": "Adjuvant Cross-over Period: Number of Participants With Premature Withdrawal From PH FDC SC Due to AEs"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/24/timeFrame",
      "value": "Up to Cycle 6 (Cycle length = 21 days)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/24/description",
      "value": "An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment.\nAn AE can therefore be any unfavorable &amp; unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study intervention.\nParticipants who discontinued the study due to AEs are reported here."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/25/measure",
      "value": "Treatment Continuation Period and Trastuzumab Emtansine IV Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/25/timeFrame",
      "value": "From initiation of study treatment until 28 days after the last treatment cycle (up to approximately 3.5 years)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/25/description",
      "value": "AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with use of a study treatment, whether or not considered related to the study treatment.\nSAE=any untoward medical occurrence that, at any dose: Results in death; Is life threatening; Requires inpatient hospitalization&#x2F;prolongation of existing hospitalization; Results in persistent disability&#x2F;incapacity &amp;&#x2F;or is a congenital anomaly&#x2F;birth defect.\nCardiac AEs=asymptomatic decline in LVEF of ≥10% from baseline to an LVEF &lt;50%; asymptomatic decline in LVEF requiring treatment&#x2F;leading to discontinuation of study treatment; CHF.\nAEs ≥Grade 3=marked limitation of physical activity.\nComfortable at rest, but any ordinary activity causes fatigue, palpitation&#x2F;dyspnea; Inability to carry any physical activity without discomfort.\nSymptoms of cardiac insufficiency at rest.\nAny physical activity leads to discomfort."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/26/measure",
      "value": "Treatment Continuation Period and Trastuzumab Emtansine IV Period: Number of Participants With Premature Withdrawal From PH FDC SC and Trastuzumab Emtansine IV Due to AEs"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/26/timeFrame",
      "value": "From initiation of study treatment in the adjuvant phase until 28 days after the last treatment cycle (up to approximately 3.5 years)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/26/description",
      "value": "An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment.\nAn AE can therefore be any unfavorable &amp; unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study intervention.\nParticipants who discontinue study due to AEs will be reported."
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/27"
    },
    {
      "op": "replace",
      "path": "/hasResults",
      "value": true
    },
    {
      "op": "add",
      "path": "/resultsSection",
      "value": {
        "adverseEventsModule": {
          "description": "SASab=all randomized participants who received at least 1 study treatment during NP.\nSAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP.\nAEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other.\nParticipants that switched between administration settings during continuation period are counted in both settings.\nFinal AE data will be reported 1 year after study completion.",
          "eventGroups": [
            {
              "deathsNumAffected": 0,
              "deathsNumAtRisk": 115,
              "description": "Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg&#x2F;kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg&#x2F;kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
              "id": "EG000",
              "otherNumAffected": 113,
              "otherNumAtRisk": 115,
              "seriousNumAffected": 19,
              "seriousNumAtRisk": 115,
              "title": "Arm A, Neoadjuvant Phase: P+H IV"
            },
            {
              "deathsNumAffected": 4,
              "deathsNumAtRisk": 228,
              "description": "Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
              "id": "EG001",
              "otherNumAffected": 222,
              "otherNumAtRisk": 228,
              "seriousNumAffected": 43,
              "seriousNumAtRisk": 228,
              "title": "Arm B, Neoadjuvant Phase: PH FDC SC"
            },
            {
              "deathsNumAffected": 0,
              "deathsNumAtRisk": 194,
              "description": "Participants who achieved pathologic complete response (pCR) after surgery received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and rHuPH20, 30,000 U, as a SC injection on Day 1 of Cycle 1 followed by maintenance dose of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, on Day 1 of Cycle 2 (Cycle length = 21 days).",
              "id": "EG002",
              "otherNumAffected": 84,
              "otherNumAtRisk": 194,
              "seriousNumAffected": 3,
              "seriousNumAtRisk": 194,
              "title": "Adjuvant Run-in Phase: PH FDC SC in Hospital"
            },
            {
              "deathsNumAffected": 0,
              "deathsNumAtRisk": 190,
              "description": "Participants who completed the run-in period received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for 3 cycles in the hospital setting during the cross-over period (Cycle length = 21 days).",
              "id": "EG003",
              "otherNumAffected": 77,
              "otherNumAtRisk": 190,
              "seriousNumAffected": 1,
              "seriousNumAtRisk": 190,
              "title": "Adjuvant Cross-Over Phase: PH FDC SC in Hospital"
            },
            {
              "deathsNumAffected": 0,
              "deathsNumAtRisk": 191,
              "description": "Participants who completed the run-in period received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for 3 cycles in the home setting during the cross-over period (Cycle length = 21 days).",
              "id": "EG004",
              "otherNumAffected": 64,
              "otherNumAtRisk": 191,
              "seriousNumAffected": 1,
              "seriousNumAtRisk": 191,
              "title": "Adjuvant Cross-Over Phase: PH FDC SC at Home"
            },
            {
              "deathsNumAffected": 0,
              "deathsNumAtRisk": 84,
              "description": "Participants who completed the cross-over period and opted to receive further treatment in the hospital setting received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection up to a maximum of 18 cycles (Cycle length = 21 days).",
              "id": "EG005",
              "otherNumAffected": 26,
              "otherNumAtRisk": 84,
              "seriousNumAffected": 1,
              "seriousNumAtRisk": 84,
              "title": "Adjuvant Continuation Phase: PH FDC SC in Hospital"
            },
            {
              "deathsNumAffected": 0,
              "deathsNumAtRisk": 114,
              "description": "Participants who completed the cross-over period and opted to receive further treatment at home received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection up to a maximum of 18 cycles (Cycle length = 21 days).",
              "id": "EG006",
              "otherNumAffected": 31,
              "otherNumAtRisk": 114,
              "seriousNumAffected": 0,
              "seriousNumAtRisk": 114,
              "title": "Adjuvant Continuation Phase: PH FDC SC at Home"
            },
            {
              "deathsNumAffected": 1,
              "deathsNumAtRisk": 117,
              "description": "Participants who did not achieve pCR after surgery received trastuzumab emtansine, 3.6 mg&#x2F;kg, as an IV infusion for 90 minutes as an initial dose.\nThereafter, participants received trastuzumab emtansine, 3.6 mg&#x2F;kg, as an IV infusion for 30 minutes, Q3W for 14 cycles (Cycle length = 21 days).",
              "id": "EG007",
              "otherNumAffected": 107,
              "otherNumAtRisk": 117,
              "seriousNumAffected": 9,
              "seriousNumAtRisk": 117,
              "title": "Arm E, Adjuvant Phase: Trastuzumab Emtansine IV"
            }
          ],
          "frequencyThreshold": "5",
          "otherEvents": [
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Blood and lymphatic system disorders",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 61,
                  "numAtRisk": 115,
                  "numEvents": 82
                },
                {
                  "groupId": "EG001",
                  "numAffected": 96,
                  "numAtRisk": 228,
                  "numEvents": 128
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 194,
                  "numEvents": 0
                },
                {
                  "groupId": "EG003",
                  "numAffected": 5,
                  "numAtRisk": 190,
                  "numEvents": 5
                },
                {
                  "groupId": "EG004",
                  "numAffected": 1,
                  "numAtRisk": 191,
                  "numEvents": 1
                },
                {
                  "groupId": "EG005",
                  "numAffected": 1,
                  "numAtRisk": 84,
                  "numEvents": 1
                },
                {
                  "groupId": "EG006",
                  "numAffected": 2,
                  "numAtRisk": 114,
                  "numEvents": 2
                },
                {
                  "groupId": "EG007",
                  "numAffected": 20,
                  "numAtRisk": 117,
                  "numEvents": 29
                }
              ],
              "term": "Anaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Blood and lymphatic system disorders",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 13,
                  "numAtRisk": 115,
                  "numEvents": 29
                },
                {
                  "groupId": "EG001",
                  "numAffected": 26,
                  "numAtRisk": 228,
                  "numEvents": 47
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 194,
                  "numEvents": 1
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 190,
                  "numEvents": 1
                },
                {
                  "groupId": "EG004",
                  "numAffected": 4,
                  "numAtRisk": 191,
                  "numEvents": 4
                },
                {
                  "groupId": "EG005",
                  "numAffected": 3,
                  "numAtRisk": 84,
                  "numEvents": 3
                },
                {
                  "groupId": "EG006",
                  "numAffected": 0,
                  "numAtRisk": 114,
                  "numEvents": 0
                },
                {
                  "groupId": "EG007",
                  "numAffected": 13,
                  "numAtRisk": 117,
                  "numEvents": 26
                }
              ],
              "term": "Leukopenia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Blood and lymphatic system disorders",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 8,
                  "numAtRisk": 115,
                  "numEvents": 17
                },
                {
                  "groupId": "EG001",
                  "numAffected": 12,
                  "numAtRisk": 228,
                  "numEvents": 18
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 194,
                  "numEvents": 0
                },
                {
                  "groupId": "EG003",
                  "numAffected": 2,
                  "numAtRisk": 190,
                  "numEvents": 2
                },
                {
                  "groupId": "EG004",
                  "numAffected": 0,
                  "numAtRisk": 191,
                  "numEvents": 0
                },
                {
                  "groupId": "EG005",
                  "numAffected": 1,
                  "numAtRisk": 84,
                  "numEvents": 1
                },
                {
                  "groupId": "EG006",
                  "numAffected": 0,
                  "numAtRisk": 114,
                  "numEvents": 0
                },
                {
                  "groupId": "EG007",
                  "numAffected": 8,
                  "numAtRisk": 117,
                  "numEvents": 9
                }
              ],
              "term": "Lymphopenia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Blood and lymphatic system disorders",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 22,
                  "numAtRisk": 115,
                  "numEvents": 36
                },
                {
                  "groupId": "EG001",
                  "numAffected": 60,
                  "numAtRisk": 228,
                  "numEvents": 97
                },
                {
                  "groupId": "EG002",
                  "numAffected": 2,
                  "numAtRisk": 194,
                  "numEvents": 2
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 190,
                  "numEvents": 1
                },
                {
                  "groupId": "EG004",
                  "numAffected": 4,
                  "numAtRisk": 191,
                  "numEvents": 4
                },
                {
                  "groupId": "EG005",
                  "numAffected": 1,
                  "numAtRisk": 84,
                  "numEvents": 1
                },
                {
                  "groupId": "EG006",
                  "numAffected": 1,
                  "numAtRisk": 114,
                  "numEvents": 1
                },
                {
                  "groupId": "EG007",
                  "numAffected": 22,
                  "numAtRisk": 117,
                  "numEvents": 52
                }
              ],
              "term": "Neutropenia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Blood and lymphatic system disorders",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 12,
                  "numAtRisk": 115,
                  "numEvents": 22
                },
                {
                  "groupId": "EG001",
                  "numAffected": 21,
                  "numAtRisk": 228,
                  "numEvents": 33
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 194,
                  "numEvents": 0
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 190,
                  "numEvents": 0
                },
                {
                  "groupId": "EG004",
                  "numAffected": 0,
                  "numAtRisk": 191,
                  "numEvents": 0
                },
                {
                  "groupId": "EG005",
                  "numAffected": 0,
                  "numAtRisk": 84,
                  "numEvents": 0
                },
                {
                  "groupId": "EG006",
                  "numAffected": 0,
                  "numAtRisk": 114,
                  "numEvents": 0
                },
                {
                  "groupId": "EG007",
                  "numAffected": 25,
                  "numAtRisk": 117,
                  "numEvents": 42
                }
              ],
              "term": "Thrombocytopenia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Eye disorders",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 4,
                  "numAtRisk": 115,
                  "numEvents": 4
                },
                {
                  "groupId": "EG001",
                  "numAffected": 15,
                  "numAtRisk": 228,
                  "numEvents": 20
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 194,
                  "numEvents": 0
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 190,
                  "numEvents": 0
                },
                {
                  "groupId": "EG004",
                  "numAffected": 0,
                  "numAtRisk": 191,
                  "numEvents": 0
                },
                {
                  "groupId": "EG005",
                  "numAffected": 0,
                  "numAtRisk": 84,
                  "numEvents": 0
                },
                {
                  "groupId": "EG006",
                  "numAffected": 0,
                  "numAtRisk": 114,
                  "numEvents": 0
                },
                {
                  "groupId": "EG007",
                  "numAffected": 1,
                  "numAtRisk": 117,
                  "numEvents": 1
                }
              ],
              "term": "Dry eye"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 5,
                  "numAtRisk": 115,
                  "numEvents": 7
                },
                {
                  "groupId": "EG001",
                  "numAffected": 18,
                  "numAtRisk": 228,
                  "numEvents": 21
                },
                {
                  "groupId": "EG002",
                  "numAffected": 2,
                  "numAtRisk": 194,
                  "numEvents": 2
                },
                {
                  "groupId": "EG003",
                  "numAffected": 3,
                  "numAtRisk": 190,
                  "numEvents": 3
                },
                {
                  "groupId": "EG004",
                  "numAffected": 1,
                  "numAtRisk": 191,
                  "numEvents": 1
                },
                {
                  "groupId": "EG005",
                  "numAffected": 0,
                  "numAtRisk": 84,
                  "numEvents": 0
                },
                {
                  "groupId": "EG006",
                  "numAffected": 0,
                  "numAtRisk": 114,
                  "numEvents": 0
                },
                {
                  "groupId": "EG007",
                  "numAffected": 6,
                  "numAtRisk": 117,
                  "numEvents": 6
                }
              ],
              "term": "Abdominal pain"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 9,
                  "numAtRisk": 115,
                  "numEvents": 12
                },
                {
                  "groupId": "EG001",
                  "numAffected": 16,
                  "numAtRisk": 228,
                  "numEvents": 20
                },
                {
                  "groupId": "EG002",
                  "numAffected": 2,
                  "numAtRisk": 194,
                  "numEvents": 2
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 190,
                  "numEvents": 0
                },
                {
                  "groupId": "EG004",
                  "numAffected": 0,
                  "numAtRisk": 191,
                  "numEvents": 0
                },
                {
                  "groupId": "EG005",
                  "numAffected": 2,
                  "numAtRisk": 84,
                  "numEvents": 2
                },
                {
                  "groupId": "EG006",
                  "numAffected": 0,
                  "numAtRisk": 114,
                  "numEvents": 0
                },
                {
                  "groupId": "EG007",
                  "numAffected": 4,
                  "numAtRisk": 117,
                  "numEvents": 9
                }
              ],
              "term": "Abdominal pain upper"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 14,
                  "numAtRisk": 115,
                  "numEvents": 14
                },
                {
                  "groupId": "EG001",
                  "numAffected": 29,
                  "numAtRisk": 228,
                  "numEvents": 45
                },
                {
                  "groupId": "EG002",
                  "numAffected": 2,
                  "numAtRisk": 194,
                  "numEvents": 2
                },
                {
                  "groupId": "EG003",
                  "numAffected": 4,
                  "numAtRisk": 190,
                  "numEvents": 4
                },
                {
                  "groupId": "EG004",
                  "numAffected": 5,
                  "numAtRisk": 191,
                  "numEvents": 5
                },
                {
                  "groupId": "EG005",
                  "numAffected": 0,
                  "numAtRisk": 84,
                  "numEvents": 0
                },
                {
                  "groupId": "EG006",
                  "numAffected": 1,
                  "numAtRisk": 114,
                  "numEvents": 1
                },
                {
                  "groupId": "EG007",
                  "numAffected": 14,
                  "numAtRisk": 117,
                  "numEvents": 15
                }
              ],
              "term": "Constipation"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 72,
                  "numAtRisk": 115,
                  "numEvents": 145
                },
                {
                  "groupId": "EG001",
                  "numAffected": 147,
                  "numAtRisk": 228,
                  "numEvents": 274
                },
                {
                  "groupId": "EG002",
                  "numAffected": 12,
                  "numAtRisk": 194,
                  "numEvents": 14
                },
                {
                  "groupId": "EG003",
                  "numAffected": 9,
                  "numAtRisk": 190,
                  "numEvents": 10
                },
                {
                  "groupId": "EG004",
                  "numAffected": 7,
                  "numAtRisk": 191,
                  "numEvents": 8
                },
                {
                  "groupId": "EG005",
                  "numAffected": 3,
                  "numAtRisk": 84,
                  "numEvents": 3
                },
                {
                  "groupId": "EG006",
                  "numAffected": 6,
                  "numAtRisk": 114,
                  "numEvents": 6
                },
                {
                  "groupId": "EG007",
                  "numAffected": 7,
                  "numAtRisk": 117,
                  "numEvents": 7
                }
              ],
              "term": "Diarrhoea"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 14,
                  "numAtRisk": 115,
                  "numEvents": 20
                },
                {
                  "groupId": "EG001",
                  "numAffected": 28,
                  "numAtRisk": 228,
                  "numEvents": 32
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 194,
                  "numEvents": 0
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 190,
                  "numEvents": 1
                },
                {
                  "groupId": "EG004",
                  "numAffected": 2,
                  "numAtRisk": 191,
                  "numEvents": 2
                },
                {
                  "groupId": "EG005",
                  "numAffected": 0,
                  "numAtRisk": 84,
                  "numEvents": 0
                },
                {
                  "groupId": "EG006",
                  "numAffected": 0,
                  "numAtRisk": 114,
                  "numEvents": 0
                },
                {
                  "groupId": "EG007",
                  "numAffected": 2,
                  "numAtRisk": 117,
                  "numEvents": 2
                }
              ],
              "term": "Dyspepsia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 7,
                  "numAtRisk": 115,
                  "numEvents": 7
                },
                {
                  "groupId": "EG001",
                  "numAffected": 14,
                  "numAtRisk": 228,
                  "numEvents": 15
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 194,
                  "numEvents": 1
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 190,
                  "numEvents": 1
                },
                {
                  "groupId": "EG004",
                  "numAffected": 0,
                  "numAtRisk": 191,
                  "numEvents": 0
                },
                {
                  "groupId": "EG005",
                  "numAffected": 2,
                  "numAtRisk": 84,
                  "numEvents": 2
                },
                {
                  "groupId": "EG006",
                  "numAffected": 0,
                  "numAtRisk": 114,
                  "numEvents": 0
                },
                {
                  "groupId": "EG007",
                  "numAffected": 3,
                  "numAtRisk": 117,
                  "numEvents": 3
                }
              ],
              "term": "Gastrooesophageal reflux disease"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 64,
                  "numAtRisk": 115,
                  "numEvents": 94
                },
                {
                  "groupId": "EG001",
                  "numAffected": 136,
                  "numAtRisk": 228,
                  "numEvents": 245
                },
                {
                  "groupId": "EG002",
                  "numAffected": 5,
                  "numAtRisk": 194,
                  "numEvents": 5
                },
                {
                  "groupId": "EG003",
                  "numAffected": 2,
                  "numAtRisk": 190,
                  "numEvents": 2
                },
                {
                  "groupId": "EG004",
                  "numAffected": 2,
                  "numAtRisk": 191,
                  "numEvents": 2
                },
                {
                  "groupId": "EG005",
                  "numAffected": 1,
                  "numAtRisk": 84,
                  "numEvents": 1
                },
                {
                  "groupId": "EG006",
                  "numAffected": 3,
                  "numAtRisk": 114,
                  "numEvents": 3
                },
                {
                  "groupId": "EG007",
                  "numAffected": 18,
                  "numAtRisk": 117,
                  "numEvents": 26
                }
              ],
              "term": "Nausea"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 13,
                  "numAtRisk": 115,
                  "numEvents": 17
                },
                {
                  "groupId": "EG001",
                  "numAffected": 31,
                  "numAtRisk": 228,
                  "numEvents": 37
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 194,
                  "numEvents": 0
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 190,
                  "numEvents": 0
                },
                {
                  "groupId": "EG004",
                  "numAffected": 1,
                  "numAtRisk": 191,
                  "numEvents": 1
                },
                {
                  "groupId": "EG005",
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              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 115,
                  "numEvents": 2
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 228,
                  "numEvents": 1
                },
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                  "groupId": "EG002",
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                  "numAtRisk": 194,
                  "numEvents": 0
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 190,
                  "numEvents": 0
                },
                {
                  "groupId": "EG004",
                  "numAffected": 0,
                  "numAtRisk": 191,
                  "numEvents": 0
                },
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                  "groupId": "EG005",
                  "numAffected": 0,
                  "numAtRisk": 84,
                  "numEvents": 0
                },
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                  "numAffected": 0,
                  "numAtRisk": 114,
                  "numEvents": 0
                },
                {
                  "groupId": "EG007",
                  "numAffected": 0,
                  "numAtRisk": 117,
                  "numEvents": 0
                }
              ],
              "term": "Pulmonary embolism"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 115,
                  "numEvents": 0
                },
                {
                  "groupId": "EG001",
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                  "numEvents": 2
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                  "numAtRisk": 194,
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                },
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                  "numAffected": 0,
                  "numAtRisk": 190,
                  "numEvents": 0
                },
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                  "numAffected": 0,
                  "numAtRisk": 191,
                  "numEvents": 0
                },
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                  "groupId": "EG005",
                  "numAffected": 0,
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                  "numEvents": 0
                },
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                  "numAffected": 0,
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                },
                {
                  "groupId": "EG007",
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                  "numAtRisk": 117,
                  "numEvents": 0
                }
              ],
              "term": "Hypotension"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
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                  "numAffected": 1,
                  "numAtRisk": 115,
                  "numEvents": 1
                },
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                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 228,
                  "numEvents": 0
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                },
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                  "numEvents": 0
                },
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                  "groupId": "EG007",
                  "numAffected": 0,
                  "numAtRisk": 117,
                  "numEvents": 0
                }
              ],
              "term": "Hypovolaemic shock"
            },
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA version 27.1",
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                  "numEvents": 0
                },
                {
                  "groupId": "EG001",
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                  "numEvents": 0
                },
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                  "numAffected": 0,
                  "numAtRisk": 194,
                  "numEvents": 0
                },
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                  "numAffected": 0,
                  "numAtRisk": 190,
                  "numEvents": 0
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                  "numEvents": 0
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                {
                  "groupId": "EG007",
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                  "numAtRisk": 117,
                  "numEvents": 1
                }
              ],
              "term": "Multiple organ dysfunction syndrome"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Hepatobiliary disorders",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 115,
                  "numEvents": 0
                },
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                  "numAffected": 0,
                  "numAtRisk": 228,
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                  "numEvents": 0
                },
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                  "numAffected": 0,
                  "numAtRisk": 190,
                  "numEvents": 0
                },
                {
                  "groupId": "EG004",
                  "numAffected": 0,
                  "numAtRisk": 191,
                  "numEvents": 0
                },
                {
                  "groupId": "EG005",
                  "numAffected": 0,
                  "numAtRisk": 84,
                  "numEvents": 0
                },
                {
                  "groupId": "EG006",
                  "numAffected": 0,
                  "numAtRisk": 114,
                  "numEvents": 0
                },
                {
                  "groupId": "EG007",
                  "numAffected": 1,
                  "numAtRisk": 117,
                  "numEvents": 2
                }
              ],
              "term": "Hypertransaminasaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 115,
                  "numEvents": 0
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 228,
                  "numEvents": 0
                },
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                  "numAffected": 0,
                  "numAtRisk": 194,
                  "numEvents": 0
                },
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                  "numAffected": 0,
                  "numAtRisk": 190,
                  "numEvents": 0
                },
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                  "groupId": "EG004",
                  "numAffected": 0,
                  "numAtRisk": 191,
                  "numEvents": 0
                },
                {
                  "groupId": "EG005",
                  "numAffected": 0,
                  "numAtRisk": 84,
                  "numEvents": 0
                },
                {
                  "groupId": "EG006",
                  "numAffected": 0,
                  "numAtRisk": 114,
                  "numEvents": 0
                },
                {
                  "groupId": "EG007",
                  "numAffected": 1,
                  "numAtRisk": 117,
                  "numEvents": 1
                }
              ],
              "term": "Pneumonia bacterial"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 115,
                  "numEvents": 0
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 228,
                  "numEvents": 0
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 194,
                  "numEvents": 0
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 190,
                  "numEvents": 0
                },
                {
                  "groupId": "EG004",
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                  "numEvents": 0
                },
                {
                  "groupId": "EG005",
                  "numAffected": 0,
                  "numAtRisk": 84,
                  "numEvents": 0
                },
                {
                  "groupId": "EG006",
                  "numAffected": 0,
                  "numAtRisk": 114,
                  "numEvents": 0
                },
                {
                  "groupId": "EG007",
                  "numAffected": 1,
                  "numAtRisk": 117,
                  "numEvents": 1
                }
              ],
              "term": "Sinusitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 115,
                  "numEvents": 0
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 228,
                  "numEvents": 0
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 194,
                  "numEvents": 0
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 190,
                  "numEvents": 0
                },
                {
                  "groupId": "EG004",
                  "numAffected": 0,
                  "numAtRisk": 191,
                  "numEvents": 0
                },
                {
                  "groupId": "EG005",
                  "numAffected": 0,
                  "numAtRisk": 84,
                  "numEvents": 0
                },
                {
                  "groupId": "EG006",
                  "numAffected": 0,
                  "numAtRisk": 114,
                  "numEvents": 0
                },
                {
                  "groupId": "EG007",
                  "numAffected": 1,
                  "numAtRisk": 117,
                  "numEvents": 1
                }
              ],
              "term": "Soft tissue infection"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Product Issues",
              "sourceVocabulary": "MedDRA version 27.1",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 115,
                  "numEvents": 0
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 228,
                  "numEvents": 0
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 194,
                  "numEvents": 0
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 190,
                  "numEvents": 0
                },
                {
                  "groupId": "EG004",
                  "numAffected": 0,
                  "numAtRisk": 191,
                  "numEvents": 0
                },
                {
                  "groupId": "EG005",
                  "numAffected": 0,
                  "numAtRisk": 84,
                  "numEvents": 0
                },
                {
                  "groupId": "EG006",
                  "numAffected": 0,
                  "numAtRisk": 114,
                  "numEvents": 0
                },
                {
                  "groupId": "EG007",
                  "numAffected": 1,
                  "numAtRisk": 117,
                  "numEvents": 1
                }
              ],
              "term": "Device breakage"
            }
          ],
          "timeFrame": "From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)"
        },
        "baselineCharacteristicsModule": {
          "denoms": [
            {
              "counts": [
                {
                  "groupId": "BG000",
                  "value": "116"
                },
                {
                  "groupId": "BG001",
                  "value": "231"
                },
                {
                  "groupId": "BG002",
                  "value": "347"
                }
              ],
              "units": "Participants"
            }
          ],
          "groups": [
            {
              "description": "Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg&#x2F;kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg&#x2F;kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
              "id": "BG000",
              "title": "Arm A, Neoadjuvant Phase: P+H IV"
            },
            {
              "description": "Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
              "id": "BG001",
              "title": "Arm B, Neoadjuvant Phase: PH FDC SC"
            },
            {
              "description": "Total of all reporting groups",
              "id": "BG002",
              "title": "Total"
            }
          ],
          "measures": [
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "spread": "11.0",
                          "value": "50.9"
                        },
                        {
                          "groupId": "BG001",
                          "spread": "11.7",
                          "value": "52.9"
                        },
                        {
                          "groupId": "BG002",
                          "spread": "11.5",
                          "value": "52.2"
                        }
                      ]
                    }
                  ]
                }
              ],
              "dispersionType": "STANDARD_DEVIATION",
              "paramType": "MEAN",
              "title": "Age, Continuous",
              "unitOfMeasure": "years"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "116"
                        },
                        {
                          "groupId": "BG001",
                          "value": "230"
                        },
                        {
                          "groupId": "BG002",
                          "value": "346"
                        }
                      ],
                      "title": "Female"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "1"
                        },
                        {
                          "groupId": "BG002",
                          "value": "1"
                        }
                      ],
                      "title": "Male"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Sex: Female, Male",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "52"
                        },
                        {
                          "groupId": "BG001",
                          "value": "93"
                        },
                        {
                          "groupId": "BG002",
                          "value": "145"
                        }
                      ],
                      "title": "Hispanic or Latino"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "54"
                        },
                        {
                          "groupId": "BG001",
                          "value": "118"
                        },
                        {
                          "groupId": "BG002",
                          "value": "172"
                        }
                      ],
                      "title": "Not Hispanic or Latino"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "10"
                        },
                        {
                          "groupId": "BG001",
                          "value": "20"
                        },
                        {
                          "groupId": "BG002",
                          "value": "30"
                        }
                      ],
                      "title": "Unknown or Not Reported"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Ethnicity (NIH&#x2F;OMB)",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "15"
                        },
                        {
                          "groupId": "BG001",
                          "value": "35"
                        },
                        {
                          "groupId": "BG002",
                          "value": "50"
                        }
                      ],
                      "title": "American Indian or Alaska Native"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "12"
                        },
                        {
                          "groupId": "BG001",
                          "value": "32"
                        },
                        {
                          "groupId": "BG002",
                          "value": "44"
                        }
                      ],
                      "title": "Asian"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "1"
                        },
                        {
                          "groupId": "BG002",
                          "value": "1"
                        }
                      ],
                      "title": "Native Hawaiian or Other Pacific Islander"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "10"
                        },
                        {
                          "groupId": "BG001",
                          "value": "23"
                        },
                        {
                          "groupId": "BG002",
                          "value": "33"
                        }
                      ],
                      "title": "Black or African American"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "66"
                        },
                        {
                          "groupId": "BG001",
                          "value": "123"
                        },
                        {
                          "groupId": "BG002",
                          "value": "189"
                        }
                      ],
                      "title": "White"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "3"
                        },
                        {
                          "groupId": "BG001",
                          "value": "4"
                        },
                        {
                          "groupId": "BG002",
                          "value": "7"
                        }
                      ],
                      "title": "More than one race"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "10"
                        },
                        {
                          "groupId": "BG001",
                          "value": "13"
                        },
                        {
                          "groupId": "BG002",
                          "value": "23"
                        }
                      ],
                      "title": "Unknown or Not Reported"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Race (NIH&#x2F;OMB)",
              "unitOfMeasure": "Participants"
            }
          ],
          "populationDescription": "Neoadjuvant full analysis set (FASab) included all randomized participants, regardless of whether they received treatment.\nThe HCPs were not enrolled in this study.\nHence, no baseline data were planned to be collected for the HCPs responding to HCPQs."
        },
        "moreInfoModule": {
          "certainAgreement": {
            "otherDetails": "The Study being conducted under this Agreement is part of the Overall Study.\nInvestigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study.\nThe Sponsor may request that Confidential Information be deleted and&#x2F;or the publication be postponed in order to protect the Sponsor&#x27;s intellectual property rights.",
            "piSponsorEmployee": false,
            "restrictionType": "OTHER",
            "restrictiveAgreement": true
          },
          "pointOfContact": {
            "email": "genentech@druginfo.com",
            "organization": "Hoffmann-La Roche",
            "phone": "800 821-8590",
            "title": "Medical Communications"
          }
        },
        "outcomeMeasuresModule": {
          "outcomeMeasures": [
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "69.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "59.0"
                        }
                      ]
                    }
                  ],
                  "title": "Home"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "23.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "39.8"
                        }
                      ]
                    }
                  ],
                  "title": "Hospital"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "8.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.2"
                        }
                      ]
                    }
                  ],
                  "title": "No Preference"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "87"
                    },
                    {
                      "groupId": "OG001",
                      "value": "83"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "The PPQ was used to evaluate the participant preference for PH FDC SC compared to P+H IV.\nParticipants completed the PPQ, where Question (Q) 1 was: &quot;All things considered, which setting for your treatment did you prefer?&quot;\nParticipants were required to select one of the following options: home, hospital or no preference.\nThe reported results show the percentage of participants who preferred receiving PH FDC SC at home setting over the hospital setting.\nPercentages were rounded off.",
              "groups": [
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).",
                  "id": "OG000",
                  "title": "Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home"
                },
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).",
                  "id": "OG001",
                  "title": "Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "Adjuvant cross-over modified intent-to-treat (mITTcross) population included all randomized participants assigned into the cross-over period who received at least one dose of PH FDC SC, completed Question 1 of the PPQ, and completed radiotherapy before entering the cross-over period.",
              "reportingStatus": "POSTED",
              "timeFrame": "Upon completion of adjuvant cross-over period (Day 1 of Cycle 8 or 9; Cycle length = 21 days)",
              "title": "Cross-over Period: Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in Question 1 of the Patient Preference Questionnaire (PPQ)",
              "type": "PRIMARY",
              "unitOfMeasure": "percentage of participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "121"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "100"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "121"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "116"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "100"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "116"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "114"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "100"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "114"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "114"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 4 Day 1: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "98.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "114"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 4 Day 1: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "113"
                        },
                        {
                          "groupId": "OG001",
                          "value": "211"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 5 Day 1: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "99.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "113"
                        },
                        {
                          "groupId": "OG001",
                          "value": "211"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 5 Day 1: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "112"
                        },
                        {
                          "groupId": "OG001",
                          "value": "207"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "99.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "112"
                        },
                        {
                          "groupId": "OG001",
                          "value": "207"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "58"
                        },
                        {
                          "groupId": "OG001",
                          "value": "111"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 7 Day 1: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "100"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "58"
                        },
                        {
                          "groupId": "OG001",
                          "value": "111"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 7 Day 1: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "56"
                        },
                        {
                          "groupId": "OG001",
                          "value": "107"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "100"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "56"
                        },
                        {
                          "groupId": "OG001",
                          "value": "107"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: P+H IV"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "113"
                    },
                    {
                      "groupId": "OG001",
                      "value": "211"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with preparation of P+H IV and&#x2F;or administration of PH FDC SC completed the following question of the HCPQ: Q1a: &quot;Please indicate which treatment preparation the estimates relate to&quot;.\nHCPs were required to select one of the following options: PH FDC SC or P+H IV.\nThe response to Q1a was used to further assess Q1b: How long did it take to prepare the treatment for use?\nPercentages were rounded off.",
              "groups": [
                {
                  "description": "Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg&#x2F;kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg&#x2F;kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG000",
                  "title": "Arm A, Neoadjuvant Phase: P+H IV"
                },
                {
                  "description": "Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG001",
                  "title": "Arm B, Neoadjuvant Phase: PH FDC SC"
                }
              ],
              "measureCategoriesReviewUnit": {
                "resetReasons": [
                  "Information here appears inconsistent with information in other parts of the record."
                ]
              },
              "paramType": "NUMBER",
              "populationDescription": "Overall number analyzed is the number of HCPs who answered Q1a of the HCPQ.\nNumber analyzed is the number of HCPs who answered Q1a of the HCPQ at the specified time point.",
              "reportingStatus": "POSTED",
              "timeFrame": "Day 1 of Cycles 1-8 (Cycle length = 21 days)",
              "title": "Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of HCPs"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "1",
                          "upperLimit": "120",
                          "value": "20.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "0",
                          "upperLimit": "30",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "120"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "1",
                          "upperLimit": "50",
                          "value": "20.5"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "0",
                          "upperLimit": "40",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "115"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "1",
                          "upperLimit": "50",
                          "value": "20.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "1",
                          "upperLimit": "35",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "113"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "1",
                          "upperLimit": "50",
                          "value": "20.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "1",
                          "upperLimit": "30",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "113"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 4 Day 1"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "1",
                          "upperLimit": "110",
                          "value": "20.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "1",
                          "upperLimit": "52",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "113"
                        },
                        {
                          "groupId": "OG001",
                          "value": "211"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 5 Day 1"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "1",
                          "upperLimit": "410",
                          "value": "20.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "1",
                          "upperLimit": "131",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "112"
                        },
                        {
                          "groupId": "OG001",
                          "value": "207"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "4",
                          "upperLimit": "90",
                          "value": "13.5"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "1",
                          "upperLimit": "45",
                          "value": "4.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "58"
                        },
                        {
                          "groupId": "OG001",
                          "value": "111"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 7 Day 1"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "4",
                          "upperLimit": "90",
                          "value": "15.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "1",
                          "upperLimit": "45",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "56"
                        },
                        {
                          "groupId": "OG001",
                          "value": "106"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "113"
                    },
                    {
                      "groupId": "OG001",
                      "value": "211"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with preparation of P+H IV and&#x2F;or administration of PH FDC SC completed the following question of the HCPQ: Q1b: &quot;How long did it take to prepare the treatment for use?&quot;\nThis was a follow up question to Q1a: &quot;Please indicate which treatment preparation the estimates relate to&quot; for which HCPs were required to select one of the following options: PH FDC SC or P+H IV.",
              "dispersionType": "Full Range",
              "groups": [
                {
                  "description": "Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg&#x2F;kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg&#x2F;kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG000",
                  "title": "Arm A, Neoadjuvant Phase: P+H IV"
                },
                {
                  "description": "Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG001",
                  "title": "Arm B, Neoadjuvant Phase: PH FDC SC"
                }
              ],
              "paramType": "MEDIAN",
              "populationDescription": "Overall number analyzed is the number of HCPs who answered Q1b of the HCPQ.\nNumber analyzed is the number of HCPs who answered Q1b of the HCPQ at the specified time point.",
              "reportingStatus": "POSTED",
              "timeFrame": "Day 1 of Cycles 1-8 (Cycle length = 21 days)",
              "title": "Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals&#x27; Responses to Question 1b of HCPQ - Drug Preparation Area",
              "type": "SECONDARY",
              "unitOfMeasure": "minutes"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "3.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "13.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "11.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "25.8"
                        },
                        {
                          "groupId": "OG001",
                          "value": "38.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "52.8"
                        },
                        {
                          "groupId": "OG001",
                          "value": "39.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "3.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "4.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "12.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "15.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "13.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "14.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "18.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "25.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "47.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "35.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "4.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "4.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "11.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "14.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "28.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "41.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "50.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "34.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "4.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2d: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2d: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "7.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2d: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "28.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "36.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2d: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "61.8"
                        },
                        {
                          "groupId": "OG001",
                          "value": "46.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2d: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "4.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2d: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2e: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "3.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2e: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2e: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "31.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "35.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2e: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "58.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "47.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2e: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "4.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2e: Not Available"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "5.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "10.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "12.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "24.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "33.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "53.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "40.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "4.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Not available"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "165"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "7.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "165"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "7.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "165"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "23.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "36.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "165"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "56.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "44.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "165"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "3.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "165"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Not available"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "89"
                    },
                    {
                      "groupId": "OG001",
                      "value": "165"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "HCP=any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with preparation of P+H IV and&#x2F;or administration of PH FDC SC completed the following question 2 of the HCPQs: In your opinion, if all P+H IV infusions were switched to PH FDC SC injections, please indicate how strongly you agree&#x2F;disagree with each of the following statements.\n2a: Staff will have increased availability for other tasks in the pharmacy.\n2b: Administrative procedures related to PH FDC SC require less time.\n2c: Using PH FDC SC provides more flexibility for pharmacy staff in managing their workload.\n2d: As PH FDC SC is fixed-dose, potential dosing errors are avoided.\n2e: As PH FDC SC is fixed-dose, there is less drug wastage.\n2f: Less storage space for PH FDC SC-related supplies is required in the pharmacy, as there is no need for reconstitution.\n2g: Number of preparation steps &amp; staff time commitment are reduced.\nPercentages were rounded off.",
              "groups": [
                {
                  "description": "Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg&#x2F;kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg&#x2F;kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG000",
                  "title": "Arm A, Neoadjuvant Phase: P+H IV"
                },
                {
                  "description": "Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG001",
                  "title": "Arm B, Neoadjuvant Phase: PH FDC SC"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "Overall number analyzed is the number of HCPs who answered Q2 of the HCPQ.\nNumber analyzed is the number of HCPs who responded to each sub-question of Q2 (Q2a-Q2g) of the HCPQ.",
              "reportingStatus": "POSTED",
              "timeFrame": "Up to Day 1 of Cycle 8 (Cycle length = 21 days)",
              "title": "Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of HCPs"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "63"
                        },
                        {
                          "groupId": "OG001",
                          "value": "122"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1a: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "100"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "63"
                        },
                        {
                          "groupId": "OG001",
                          "value": "122"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1a: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "24.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1b: Yes"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "75.8"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1b: No"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "90.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "43"
                        },
                        {
                          "groupId": "OG001",
                          "value": "7"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1c: Peripheral Vein Cannulation"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "43"
                        },
                        {
                          "groupId": "OG001",
                          "value": "7"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1c: PICC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "9.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "43"
                        },
                        {
                          "groupId": "OG001",
                          "value": "7"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1c: Central Venous Catheter"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "40.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "15"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1d: Central Venous Catheter"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "33.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "50.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "15"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1d: PICC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "26.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "50.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "15"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1d: Port-a-Cath"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "15"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1d: Tunneled Central Venous Catheter"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "50.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "16.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1e: Within 7 Days Prior Today"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "33.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1e: &gt; 7 &lt; 14 Days Prior Today"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1e: &gt; 14 &lt; 30 Days Prior Today"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "50.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "50.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1e: Other"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "118"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1a: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "100"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "118"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1a: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "23.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "60.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1b: Yes"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "77.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "40.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1b: No"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "88.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "66.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "44"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1c: Peripheral Vein Cannulation"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "44"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1c: PICC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "11.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "33.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "44"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1c: Central Venous Catheter"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "35.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "40.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "14"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1d: Central Venous Catheter"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "28.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "20.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "14"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1d: PICC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "35.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "40.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "14"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1d: Port-a-Cath"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "14"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1d: Tunneled Central Venous Catheter"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "8"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1e: Within 7 Days Prior Today"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "8"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1e: &gt; 7 &lt; 14 Days Prior Today"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "16.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "62.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "8"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1e: &gt; 14 &lt; 30 Days Prior Today"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "83.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "37.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "8"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1e: Other"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "113"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1a: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "100"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "113"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1a: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "26.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1b: Yes"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "73.8"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1b: No"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "88.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "42"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1c: Peripheral Vein Cannulation"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
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                  ],
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                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "33.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "57"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: Q1b: Yes"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "66.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "57"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: Q1b: No"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "97.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "38"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: Q1c: Peripheral Vein Cannulation"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "38"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: Q1c: PICC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "38"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: Q1c: Central Venous Catheter"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "10.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "19"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: Q1d: Central Venous Catheter"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "47.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "100"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "19"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: Q1d: PICC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "31.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "19"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: Q1d: Port-a-Cath"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "10.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "19"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: Q1d: Tunneled Central Venous Catheter"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "20.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "14.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "15"
                        },
                        {
                          "groupId": "OG001",
                          "value": "14"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: Q1e: Within 7 Days Prior Today"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "13.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "28.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "15"
                        },
                        {
                          "groupId": "OG001",
                          "value": "14"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: Q1e: &gt; 7 &lt; 14 Days Prior Today"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "20.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "15"
                        },
                        {
                          "groupId": "OG001",
                          "value": "14"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: Q1e: &gt; 14 &lt; 30 Days Prior Today"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "46.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "57.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "15"
                        },
                        {
                          "groupId": "OG001",
                          "value": "14"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: Q1e: Other"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "112"
                    },
                    {
                      "groupId": "OG001",
                      "value": "213"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "<p>HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with administration of P+H IV and&#x2F;or PH FDC SC completed the following Questions of the HCPQ: Q1a: Please indicate which treatment preparation the estimates relate to.\nQ1b: Did the participant have existing IV access?\nQ1c: If new IV access was needed for this cycle of treatment, please indicate what type of IV access was provided.\nQ1d: What type of existing IV access did the participant have?\nQ1e: When did the existing IV access place?\nPercentages were rounded off.</p><p>PICC = peripherally inserted central catheter.</p>",
              "groups": [
                {
                  "description": "Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg&#x2F;kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg&#x2F;kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG000",
                  "title": "Arm A, Neoadjuvant Phase: P+H IV"
                },
                {
                  "description": "Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG001",
                  "title": "Arm B, Neoadjuvant Phase: PH FDC SC"
                }
              ],
              "measureCategoriesReviewUnit": {
                "resetReasons": [
                  "Information here appears inconsistent with information in other parts of the record."
                ]
              },
              "paramType": "NUMBER",
              "populationDescription": "Overall number analyzed is the number of HCPs who answered Q1a to Q1e of the HCPQ.\nNumber analyzed is the number of HCPs who answered Q1a to Q1e of the HCPQ at the specified time point.",
              "reportingStatus": "POSTED",
              "timeFrame": "Day 1 of Cycles 1-8 (Cycle length = 21 days)",
              "title": "Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of HCPs"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "1",
                          "upperLimit": "150",
                          "value": "5.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "1",
                          "upperLimit": "308",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "46"
                        },
                        {
                          "groupId": "OG001",
                          "value": "8"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1c"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "60",
                          "upperLimit": "390",
                          "value": "180.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "5",
                          "upperLimit": "30",
                          "value": "8.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "121"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1f"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "120",
                          "upperLimit": "520",
                          "value": "420.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "8",
                          "upperLimit": "424",
                          "value": "180.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "63"
                        },
                        {
                          "groupId": "OG001",
                          "value": "121"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 1 Day 1: Q1g"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "1",
                          "upperLimit": "18",
                          "value": "5.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "2",
                          "upperLimit": "6",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "46"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1c"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "5",
                          "upperLimit": "360",
                          "value": "82.5"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "5",
                          "upperLimit": "190",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "58"
                        },
                        {
                          "groupId": "OG001",
                          "value": "118"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1f"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "90",
                          "upperLimit": "503",
                          "value": "300.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "5",
                          "upperLimit": "330",
                          "value": "180.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "118"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 2 Day 1: Q1g"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "1",
                          "upperLimit": "20",
                          "value": "5.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "5",
                          "upperLimit": "10",
                          "value": "10.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "43"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1c"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "5",
                          "upperLimit": "360",
                          "value": "90.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "3",
                          "upperLimit": "159",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "59"
                        },
                        {
                          "groupId": "OG001",
                          "value": "111"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1f"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "90",
                          "upperLimit": "500",
                          "value": "280.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "6",
                          "upperLimit": "480",
                          "value": "180.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "111"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1g"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "2",
                          "upperLimit": "20",
                          "value": "5.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "5",
                          "upperLimit": "10",
                          "value": "6.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "40"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 4 Day 1: Q1c"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "14",
                          "upperLimit": "365",
                          "value": "90.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "3",
                          "upperLimit": "15",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "57"
                        },
                        {
                          "groupId": "OG001",
                          "value": "112"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 4 Day 1: Q1f"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "30",
                          "upperLimit": "560",
                          "value": "270.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "6",
                          "upperLimit": "480",
                          "value": "170.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "113"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 4 Day 1: Q1g"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "1",
                          "upperLimit": "150",
                          "value": "5.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "1",
                          "upperLimit": "10",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "71"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 5 Day 1: Q1c"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "8",
                          "upperLimit": "360",
                          "value": "145.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "4",
                          "upperLimit": "250",
                          "value": "8.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "108"
                        },
                        {
                          "groupId": "OG001",
                          "value": "210"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 5 Day 1: Q1f"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "30",
                          "upperLimit": "552",
                          "value": "294.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "5",
                          "upperLimit": "420",
                          "value": "150.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "112"
                        },
                        {
                          "groupId": "OG001",
                          "value": "212"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 5 Day 1: Q1g"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "1",
                          "upperLimit": "25",
                          "value": "5.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "2",
                          "upperLimit": "5",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "74"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1c"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "8",
                          "upperLimit": "360",
                          "value": "90.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "4",
                          "upperLimit": "80",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "108"
                        },
                        {
                          "groupId": "OG001",
                          "value": "204"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1f"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "35",
                          "upperLimit": "510",
                          "value": "260.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "5",
                          "upperLimit": "370",
                          "value": "150.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "109"
                        },
                        {
                          "groupId": "OG001",
                          "value": "203"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1g"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "1",
                          "upperLimit": "30",
                          "value": "5.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "3",
                          "upperLimit": "3",
                          "value": "3.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "41"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 7 Day 1: Q1c"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "8",
                          "upperLimit": "210",
                          "value": "90.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "4",
                          "upperLimit": "75",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "57"
                        },
                        {
                          "groupId": "OG001",
                          "value": "110"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 7 Day 1: Q1f"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "40",
                          "upperLimit": "480",
                          "value": "190.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "5",
                          "upperLimit": "360",
                          "value": "115.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "57"
                        },
                        {
                          "groupId": "OG001",
                          "value": "111"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 7 Day 1: Q1g"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "1",
                          "upperLimit": "20",
                          "value": "5.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "4",
                          "upperLimit": "8",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "38"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: Q1c"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "5",
                          "upperLimit": "180",
                          "value": "90.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "3",
                          "upperLimit": "25",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "57"
                        },
                        {
                          "groupId": "OG001",
                          "value": "106"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: Q1f"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "60",
                          "upperLimit": "535",
                          "value": "180.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "6",
                          "upperLimit": "345",
                          "value": "120.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "57"
                        },
                        {
                          "groupId": "OG001",
                          "value": "106"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 8 Day 1: Q1g"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "112"
                    },
                    {
                      "groupId": "OG001",
                      "value": "212"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with administration of P+H IV and&#x2F;or PH FDC SC completed the following Questions of the HCPQ: Q1c: If new IV access was needed for this cycle of treatment, how long (in minutes) this took to set up? Q1f: How long (in minutes) did it take to administer the treatment (P+H IV or PH FDC SC)? Q1g: How long (in minutes) was the participant in the Treatment Area in total?\nPercentages have been rounded off.",
              "dispersionType": "Full Range",
              "groups": [
                {
                  "description": "Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg&#x2F;kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg&#x2F;kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG000",
                  "title": "Arm A, Neoadjuvant Phase: P+H IV"
                },
                {
                  "description": "Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG001",
                  "title": "Arm B, Neoadjuvant Phase: PH FDC SC"
                }
              ],
              "paramType": "MEDIAN",
              "populationDescription": "Overall number analyzed is the number of HCPs who answered Q1c, Q1f and Q1g of the HCPQ.\nNumber analyzed is the number of HCPs who answered Q1c, Q1f and Q1g of the HCPQ at the specified time point.",
              "reportingStatus": "POSTED",
              "timeFrame": "Day 1 of Cycles 1-8 (Cycle length = 21 days)",
              "title": "Neoadjuvant Phase: Duration of Treatment Administration According to HCPs&#x27; Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment",
              "type": "SECONDARY",
              "unitOfMeasure": "minutes"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "8.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "13.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "14.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "13.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "36.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "28.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "32.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "33.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "8.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "7.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "164"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "9.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "12.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "13.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "37.8"
                        },
                        {
                          "groupId": "OG001",
                          "value": "34.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "33.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "35.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "7.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "7.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "9.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "10.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "10.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "32.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "35.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "39.8"
                        },
                        {
                          "groupId": "OG001",
                          "value": "37.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "7.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "7.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2d: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "8.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2d: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "15.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "15.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2d: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "34.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "37.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2d: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "35.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "31.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2d: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "7.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2d: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "165"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2e: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "5.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "165"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2e: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "27.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "25.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "165"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2e: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "26.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "27.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "165"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2e: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "34.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "32.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "165"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2e: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "7.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "165"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2e: Not Applicable"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "98"
                    },
                    {
                      "groupId": "OG001",
                      "value": "166"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "HCP was defined as any personnel involved in the drug preparation &amp;&#x2F;or drug administration processes.\nHCPs who have had experience with administration of P+H IV &amp;&#x2F;or PH FDC SC completed Q2 (2a-2e) of the HCPQ: In your opinion, if all P+H IV infusions were switched to PH FDC SC injections, please indicate how strongly you agree&#x2F;disagree with each of the following statements.\n2a: Participants may be moved out of the Treatment Area (for infusion treatment) to receive PH FDC SC injections.\n2b: PH FDC SC&#x27;s SC route of administration allows for more flexible treatment scheduling.\n2c: Frees up infusion chairs for participants whose treatments can only be given IV.\n2d: Waiting list for any P+H IV treatment at the Treatment Area is reduced.\n2e: Staff&#x27;s work burden is reduced, enhancing work performance.\nThe 6 available options were: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree and Not applicable.\nPercentages were rounded off.",
              "groups": [
                {
                  "description": "Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg&#x2F;kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg&#x2F;kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG000",
                  "title": "Arm A, Neoadjuvant Phase: P+H IV"
                },
                {
                  "description": "Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG001",
                  "title": "Arm B, Neoadjuvant Phase: PH FDC SC"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "Overall number analyzed is the number of HCPs who answered any sub part Q2 (2a to 2e) of the HCPQ.\nNumber analyzed is the number of HCPs who answered each sub-question of Q2 (2a to 2e) of the HCPQ.",
              "reportingStatus": "POSTED",
              "timeFrame": "Up to Cycle 8 (Cycle length = 21 days)",
              "title": "Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of HCPs"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "8.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "20.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "34.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "33.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "22.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "31.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "28.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "7.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "5.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "25.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "36.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "31.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "22.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "29.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "25.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "7.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2h: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2h: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "23.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "31.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2h: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "30.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "25.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2h: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "33.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "28.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2h: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "8.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "98"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2h: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2i: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2i: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "4.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2i: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "26.8"
                        },
                        {
                          "groupId": "OG001",
                          "value": "31.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2i: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "61.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "53.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2i: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "8.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2i: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2j: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2j: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "20.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "21.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2j: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "35.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "31.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2j: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "35.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "32.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2j: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "7.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "12.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "166"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2j: Not Applicable"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "98"
                    },
                    {
                      "groupId": "OG001",
                      "value": "166"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "HCP was defined as any personnel involved in the drug preparation &amp;&#x2F;or drug administration processes.\nHCPs who have had experience with administration of P+H IV &amp;&#x2F;or PH FDC SC completed Question 2 (2f to 2j) of the HCPQ: In your opinion, if all P+H IV infusions were switched to PH FDC SC injections, please indicate how strongly you agree&#x2F;disagree with each of the following statements.\n2f: More interaction time between HCPs and participants.\n2g: Staff have more time for further professional education&#x2F;development.\n2h: Staff has more time for administrative tasks.\n2i: Participants on PH FDC SC spend less time in the Treatment Area.\n2j: Participants prefer PH FDC SC to P+H IV.\nThe 6 available options were: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree and Not applicable.\nPercentages were rounded off.",
              "groups": [
                {
                  "description": "Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg&#x2F;kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg&#x2F;kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG000",
                  "title": "Arm A, Neoadjuvant Phase: P+H IV"
                },
                {
                  "description": "Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG001",
                  "title": "Arm B, Neoadjuvant Phase: PH FDC SC"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "Overall number analyzed is the number of HCPs who answered any sub part of Q2 (2f to 2j) of the HCPQ.\nNumber analyzed is the number of HCPs who answered each sub-question of Q2 (2f to 2j) of the HCPQ.",
              "reportingStatus": "POSTED",
              "timeFrame": "Up to Cycle 8 (Cycle length = 21 days)",
              "title": "Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of HCPs"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "8.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "161"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q3: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "68.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "83.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "161"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q3: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "13.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "8.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "161"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q3: No Difference"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "10.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "161"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q3: Unsure"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "5.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q4: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "69.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "82.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q4: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "22.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "13.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q4: No Difference"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q4: Unsure"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q5: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "92.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "97.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q5: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "8.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q5: No Difference"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q5: Unsure"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q6: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "83.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "88.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q6: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "17.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "10.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q6: No Difference"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q6: Unsure"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q7: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "96.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "98.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q7: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q7: No Difference"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q7: Unsure"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "87"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q8: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "73.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "82.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "87"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q8: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "26.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "16.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "87"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q8: No Difference"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "87"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q8: Unsure"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "12.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "8.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "87"
                        },
                        {
                          "groupId": "OG001",
                          "value": "161"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q9: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "73.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "73.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "87"
                        },
                        {
                          "groupId": "OG001",
                          "value": "161"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q9: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "13.8"
                        },
                        {
                          "groupId": "OG001",
                          "value": "17.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "87"
                        },
                        {
                          "groupId": "OG001",
                          "value": "161"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q9: No Difference"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "87"
                        },
                        {
                          "groupId": "OG001",
                          "value": "161"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q9: Unsure"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "7.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q10: P+H IV"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "66.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "73.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q10: PH FDC SC"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "10.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "7.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q10: No Difference"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "15.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "17.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "162"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q10: Unsure"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "75.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "79.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "158"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q11: Always"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "24.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "19.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "158"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q11: Sometimes"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "158"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q11: Never"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "98"
                    },
                    {
                      "groupId": "OG001",
                      "value": "166"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "HCPs who have had experience with administration of P+H IV &amp;&#x2F;or PH FDC SC completed Questions 3 to 11 of the HCPQ: Q3: Which was more convenient for the participant?\nQ4: Which was better for optimising participant care at your institution?\nQ5: Which required less time to administer (excluding observation period)?\nQ6: Which required less use of institutional resources (e.g., staff time, facility costs, equipment use)?\nQ7: Which required less time to administer all the treatment (including IV chemotherapy)?\nQ8: Which allowed for attending to more participants because of time savings from the mode of administration of pertuzumab and trastuzumab?\nQ9: During the NP you had to administer IV chemotherapy through participant&#x27;s IV access.\nYou prefer to accompany IV chemotherapy with?\nQ10: Which was preferred by participants?\nQ11: How frequently would you recommend PH FDC SC administration to your participants in the future?\nPercentages were rounded off.",
              "groups": [
                {
                  "description": "Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg&#x2F;kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg&#x2F;kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG000",
                  "title": "Arm A, Neoadjuvant Phase: P+H IV"
                },
                {
                  "description": "Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG001",
                  "title": "Arm B, Neoadjuvant Phase: PH FDC SC"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "Overall number analyzed is the number of HCPs who answered any of the questions from Q3 to Q11 of the HCPQ.\nNumber analyzed is the number of HCPs who answered each specific question (Q3 to Q11) of the HCPQ.",
              "reportingStatus": "POSTED",
              "timeFrame": "Up to Cycle 8 (Cycle length = 21 days)",
              "title": "Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of HCPs"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "60.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "60.9"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "113"
                    },
                    {
                      "groupId": "OG001",
                      "value": "207"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "pCR was defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0&#x2F;Tis ypN0), according to the current American Joint Committee on Cancer (AJCC) staging system classification.\nPercentages were rounded off.",
              "groups": [
                {
                  "description": "Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg&#x2F;kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg&#x2F;kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG000",
                  "title": "Arm A, Neoadjuvant Phase: P+H IV"
                },
                {
                  "description": "Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG001",
                  "title": "Arm B, Neoadjuvant Phase: PH FDC SC"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "FASab included all randomized participants, regardless of whether they received treatment.\nOverall number analyzed is the number of participants with data available for analysis.",
              "reportingStatus": "POSTED",
              "reviewUnit": {
                "resetReasons": [
                  "The Time Frame appears inconsistent with information provided here or in other parts of the record."
                ]
              },
              "timeFrame": "Up to approximately 28 months",
              "title": "Percentage of Participants Who Achieved pCR Post-surgery",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "18.40",
                          "value": "79.86"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "20.92",
                          "value": "75.97"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "115"
                        },
                        {
                          "groupId": "OG001",
                          "value": "223"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - GHS&#x2F;QoL"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "21.27",
                          "value": "-9.43"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "24.64",
                          "value": "-7.40"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "107"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - GHS&#x2F;QoL"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "19.73",
                          "value": "-10.42"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "26.78",
                          "value": "-11.75"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "52"
                        },
                        {
                          "groupId": "OG001",
                          "value": "95"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 8 Day 1 - GHS&#x2F;QoL"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "11.84",
                          "value": "91.65"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "12.45",
                          "value": "91.84"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "115"
                        },
                        {
                          "groupId": "OG001",
                          "value": "223"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Physical functioning (PF)"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "16.18",
                          "value": "-12.65"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "18.56",
                          "value": "-16.01"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "107"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - PF"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "19.28",
                          "value": "-16.03"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "16.25",
                          "value": "-13.00"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "52"
                        },
                        {
                          "groupId": "OG001",
                          "value": "95"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 8 Day 1 - PF"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "15.82",
                          "value": "91.88"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "19.11",
                          "value": "91.48"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "115"
                        },
                        {
                          "groupId": "OG001",
                          "value": "223"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Role Functioning (RF)"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "28.78",
                          "value": "-15.85"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "29.46",
                          "value": "-21.18"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "107"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - RF"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "27.62",
                          "value": "-19.87"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "27.98",
                          "value": "-14.91"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "52"
                        },
                        {
                          "groupId": "OG001",
                          "value": "95"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 8 Day 1 - RF"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "22.13",
                          "value": "73.41"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "22.54",
                          "value": "71.45"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "115"
                        },
                        {
                          "groupId": "OG001",
                          "value": "223"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Emotional Functioning (EF)"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "26.06",
                          "value": "-5.87"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "25.20",
                          "value": "1.01"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "107"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - EF"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "24.09",
                          "value": "5.29"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "25.01",
                          "value": "5.85"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "52"
                        },
                        {
                          "groupId": "OG001",
                          "value": "95"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 8 Day 1 - EF"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "19.01",
                          "value": "88.41"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "17.62",
                          "value": "88.19"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "115"
                        },
                        {
                          "groupId": "OG001",
                          "value": "223"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Cognitive functioning (CF)"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "22.39",
                          "value": "-12.02"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "23.53",
                          "value": "-10.28"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "107"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - CF"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "25.21",
                          "value": "-9.62"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "18.78",
                          "value": "-4.74"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "52"
                        },
                        {
                          "groupId": "OG001",
                          "value": "95"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 8 Day 1 - CF"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "22.96",
                          "value": "86.67"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "24.56",
                          "value": "84.30"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "115"
                        },
                        {
                          "groupId": "OG001",
                          "value": "223"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Social Functioning (SF)"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "30.01",
                          "value": "-18.03"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "32.55",
                          "value": "-15.26"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "107"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - SF"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "27.82",
                          "value": "-14.42"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "25.59",
                          "value": "-7.54"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "52"
                        },
                        {
                          "groupId": "OG001",
                          "value": "95"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 8 Day 1 - SF"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "20.29",
                          "value": "15.85"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "17.74",
                          "value": "16.44"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "115"
                        },
                        {
                          "groupId": "OG001",
                          "value": "223"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Fatigue"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "26.23",
                          "value": "24.04"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "25.91",
                          "value": "27.21"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "107"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - Fatigue"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "24.33",
                          "value": "23.29"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "24.31",
                          "value": "20.23"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "52"
                        },
                        {
                          "groupId": "OG001",
                          "value": "95"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 8 Day 1 - Fatigue"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "11.60",
                          "value": "4.06"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "10.25",
                          "value": "3.36"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "115"
                        },
                        {
                          "groupId": "OG001",
                          "value": "223"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Nausea &amp; Vomiting"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "24.69",
                          "value": "19.95"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "22.82",
                          "value": "14.80"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "107"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - Nausea &amp; Vomiting"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "20.88",
                          "value": "3.21"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "17.64",
                          "value": "4.74"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "52"
                        },
                        {
                          "groupId": "OG001",
                          "value": "95"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 8 Day 1 - Nausea &amp; Vomiting"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "18.25",
                          "value": "12.17"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "19.14",
                          "value": "14.13"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "115"
                        },
                        {
                          "groupId": "OG001",
                          "value": "223"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Pain"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "27.53",
                          "value": "14.21"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "25.83",
                          "value": "7.79"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "107"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - Pain"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "29.21",
                          "value": "11.86"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "21.59",
                          "value": "8.07"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "52"
                        },
                        {
                          "groupId": "OG001",
                          "value": "95"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 8 Day 1 - Pain"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "14.32",
                          "value": "4.35"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "16.45",
                          "value": "6.28"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "115"
                        },
                        {
                          "groupId": "OG001",
                          "value": "223"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Dyspnoea"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "23.49",
                          "value": "8.74"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "24.88",
                          "value": "12.46"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "107"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - Dyspnoea"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "28.97",
                          "value": "13.46"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "23.11",
                          "value": "6.67"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "52"
                        },
                        {
                          "groupId": "OG001",
                          "value": "95"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 8 Day 1 - Dyspnoea"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "30.14",
                          "value": "25.22"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "28.07",
                          "value": "24.51"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "115"
                        },
                        {
                          "groupId": "OG001",
                          "value": "223"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Insomnia"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "32.48",
                          "value": "4.37"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "35.33",
                          "value": "3.12"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "107"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - Insomnia"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "40.75",
                          "value": "8.97"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "33.84",
                          "value": "9.12"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "52"
                        },
                        {
                          "groupId": "OG001",
                          "value": "95"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 8 Day 1 - Insomnia"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "20.16",
                          "value": "8.41"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "20.51",
                          "value": "9.72"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "115"
                        },
                        {
                          "groupId": "OG001",
                          "value": "223"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Appetite Loss"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "32.22",
                          "value": "21.31"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "33.89",
                          "value": "23.99"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "107"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - Appetite Loss"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "33.97",
                          "value": "16.03"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "35.65",
                          "value": "15.09"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "52"
                        },
                        {
                          "groupId": "OG001",
                          "value": "95"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 8 Day 1 - Appetite Loss"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "21.07",
                          "value": "9.57"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "20.56",
                          "value": "9.87"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "115"
                        },
                        {
                          "groupId": "OG001",
                          "value": "223"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Constipation"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "29.44",
                          "value": "7.65"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "25.69",
                          "value": "5.61"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "107"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - Constipation"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "21.95",
                          "value": "2.61"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "24.73",
                          "value": "3.86"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "51"
                        },
                        {
                          "groupId": "OG001",
                          "value": "95"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 8 Day 1 - Constipation"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "13.07",
                          "value": "3.77"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "14.86",
                          "value": "4.93"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "115"
                        },
                        {
                          "groupId": "OG001",
                          "value": "223"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Diarrhoea"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "33.55",
                          "value": "25.68"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "34.31",
                          "value": "28.04"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "107"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - Diarrhoea"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "26.37",
                          "value": "32.05"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "33.68",
                          "value": "27.37"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "52"
                        },
                        {
                          "groupId": "OG001",
                          "value": "95"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 8 Day 1 - Diarrhoea"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "34.14",
                          "value": "26.09"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "32.67",
                          "value": "23.17"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "115"
                        },
                        {
                          "groupId": "OG001",
                          "value": "223"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Financial Difficulties"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "41.95",
                          "value": "6.01"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "35.93",
                          "value": "7.79"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "61"
                        },
                        {
                          "groupId": "OG001",
                          "value": "107"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - Financial Difficulties"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "28.80",
                          "value": "6.41"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "33.66",
                          "value": "-1.40"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "52"
                        },
                        {
                          "groupId": "OG001",
                          "value": "95"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 8 Day 1 - Financial Difficulties"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "115"
                    },
                    {
                      "groupId": "OG001",
                      "value": "223"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions used to assess the HRQoL in cancer participants.\nFirst 28 questions evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).\nThese questions used a 4-point scale, with scores ranging from 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much).\nThe last 2 questions represented the participant&#x27;s assessment of global health status (GHS) and quality of life (QoL), using a 7-point scale with scores ranging from 0-7 (1=very poor to 7=excellent).\nEORTC QLQ-C30 scores were linearly transformed on a scale of 0 - 100, with a high score indicating better GHS&#x2F;QOL.\nNegative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.",
              "dispersionType": "Standard Deviation",
              "groups": [
                {
                  "description": "Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg&#x2F;kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg&#x2F;kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG000",
                  "title": "Arm A, Neoadjuvant Phase: P+H IV"
                },
                {
                  "description": "Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG001",
                  "title": "Arm B, Neoadjuvant Phase: PH FDC SC"
                }
              ],
              "paramType": "MEAN",
              "populationDescription": "FASab included all randomized participants, regardless of whether they received treatment.\nOverall number analyzed is the number of participants with data available for analysis.\nNumber analyzed is the number of participants with data available for analysis at the specified timepoint.",
              "reportingStatus": "POSTED",
              "reviewUnit": {
                "resetReasons": [
                  "The description of the scale or categories does not include sufficient information to understand the results reported."
                ]
              },
              "timeFrame": "Baseline, Day 1 of Cycles 6 and 8 (Cycle length = 21 days)",
              "title": "Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores",
              "type": "SECONDARY",
              "unitOfMeasure": "score on a scale"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "17.09",
                          "value": "76.98"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "18.63",
                          "value": "71.79"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "96"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - GHS&#x2F;QoL"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "13.72",
                          "value": "0.66"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "18.57",
                          "value": "0.09"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "91"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 1 Day 1- GHS&#x2F;QoL"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "14.53",
                          "value": "2.08"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "20.59",
                          "value": "5.15"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "89"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 3 Day 1 - GHS&#x2F;QoL"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "16.61",
                          "value": "-0.57"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "19.99",
                          "value": "2.48"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "84"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - GHS&#x2F;QoL"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "15.89",
                          "value": "82.61"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "16.20",
                          "value": "80.35"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "96"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - PF"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "13.19",
                          "value": "2.50"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "14.44",
                          "value": "1.83"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "91"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 1 Day 1 - PF"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "13.65",
                          "value": "2.50"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "14.18",
                          "value": "5.99"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "91"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 3 Day 1 - PF"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "16.97",
                          "value": "4.13"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "14.99",
                          "value": "2.46"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "84"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - PF"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "21.40",
                          "value": "78.35"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "29.72",
                          "value": "66.67"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "96"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - RF"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "21.61",
                          "value": "4.92"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "27.84",
                          "value": "10.62"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "91"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 1 Day 1 - RF"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "23.61",
                          "value": "6.25"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "31.33",
                          "value": "17.23"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "89"
                        }
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                          "spread": "23.53",
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                          "value": "16.07"
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                          "value": "0.34"
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                          "value": "2.27"
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                          "value": "3.46"
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                          "groupId": "OG000",
                          "spread": "21.86",
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                          "value": "0.60"
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                          "groupId": "OG000",
                          "spread": "21.14",
                          "value": "84.54"
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                          "value": "79.51"
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                          "groupId": "OG000",
                          "spread": "21.05",
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                          "groupId": "OG000",
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                          "value": "1.12"
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                          "groupId": "OG000",
                          "spread": "22.30",
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                          "groupId": "OG000",
                          "spread": "22.65",
                          "value": "80.58"
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                          "value": "70.49"
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                          "groupId": "OG000",
                          "spread": "22.34",
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                          "groupId": "OG000",
                          "spread": "20.69",
                          "value": "1.70"
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                          "groupId": "OG001",
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                          "value": "9.74"
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                          "groupId": "OG000",
                          "spread": "21.64",
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                          "groupId": "OG001",
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                          "value": "9.92"
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                          "groupId": "OG000",
                          "spread": "21.92",
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                          "groupId": "OG001",
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                          "value": "31.83"
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                      "measurements": [
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                          "groupId": "OG000",
                          "spread": "17.55",
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                          "groupId": "OG001",
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                          "value": "-0.61"
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                          "groupId": "OG000",
                          "spread": "18.66",
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                          "groupId": "OG000",
                          "spread": "24.09",
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                      "measurements": [
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                          "groupId": "OG000",
                          "spread": "10.96",
                          "value": "4.64"
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                          "value": "5.38"
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                          "groupId": "OG000",
                          "spread": "11.95",
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                          "groupId": "OG001",
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                          "groupId": "OG000",
                          "spread": "11.43",
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                          "groupId": "OG001",
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                          "groupId": "OG000",
                          "spread": "12.21",
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                          "groupId": "OG001",
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                          "groupId": "OG000",
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                          "groupId": "OG000",
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                          "groupId": "OG000",
                          "spread": "20.18",
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                          "groupId": "OG000",
                          "spread": "23.59",
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                {
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                          "groupId": "OG000",
                          "spread": "17.68",
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                          "groupId": "OG000",
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                          "groupId": "OG000",
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                          "groupId": "OG000",
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                          "groupId": "OG000",
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                          "groupId": "OG000",
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                          "groupId": "OG000",
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                {
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                      "measurements": [
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                          "groupId": "OG000",
                          "spread": "18.35",
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                          "value": "96"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Appetite loss"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "27.59",
                          "value": "2.27"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "29.07",
                          "value": "2.56"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "91"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 1 Day 1 - Appetite loss"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "25.01",
                          "value": "-0.38"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "25.62",
                          "value": "0.00"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "89"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 3 Day 1 - Appetite loss"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "24.47",
                          "value": "-1.14"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "25.87",
                          "value": "0.00"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "84"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - Appetite loss"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "22.95",
                          "value": "13.75"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "22.51",
                          "value": "13.89"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "96"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Constipation"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "21.45",
                          "value": "-2.62"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "19.25",
                          "value": "0.00"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "91"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 1 Day 1 - Constipation"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "23.99",
                          "value": "-4.92"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "25.62",
                          "value": "0.00"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "89"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 3 Day 1 - Constipation"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "27.88",
                          "value": "-3.79"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "21.55",
                          "value": "1.98"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "84"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - Constipation"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "25.15",
                          "value": "12.37"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "22.75",
                          "value": "12.15"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "96"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Diarrhoea"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "26.74",
                          "value": "0.00"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "33.17",
                          "value": "4.76"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "91"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 1 Day 1 - Diarrhoea"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "24.50",
                          "value": "-0.38"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "32.10",
                          "value": "2.25"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "89"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 3 Day 1 - Diarrhoea"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "29.62",
                          "value": "1.89"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "32.37",
                          "value": "4.76"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "84"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - Diarrhoea"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "34.14",
                          "value": "28.18"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "34.35",
                          "value": "32.29"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "97"
                        },
                        {
                          "groupId": "OG001",
                          "value": "96"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Baseline - Financial difficulties"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "24.04",
                          "value": "-6.37"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "28.20",
                          "value": "-4.40"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "89"
                        },
                        {
                          "groupId": "OG001",
                          "value": "91"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 1 Day 1 - Financial Difficulties"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "27.00",
                          "value": "-4.92"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "29.68",
                          "value": "-6.37"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "89"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 3 Day 1 - Financial Difficulties"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "27.32",
                          "value": "-2.65"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "30.82",
                          "value": "-6.35"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "88"
                        },
                        {
                          "groupId": "OG001",
                          "value": "84"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Change at Cycle 6 Day 1 - Financial Difficulties"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "98"
                    },
                    {
                      "groupId": "OG001",
                      "value": "96"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions used to assess the HRQoL in cancer participants.\nFirst 28 questions evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).\nThese questions used a 4-point scale, with scores ranging from 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much).\nThe last 2 questions represented the participant&#x27;s assessment of GHS&#x2F;QoL, using a 7-point scale with scores ranging from 0-7 (1=very poor to 7=excellent).\nEORTC QLQ-C30 scores were linearly transformed on a scale of 0 - 100, with a high score indicating better GHS&#x2F;QOL.\nNegative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.",
              "dispersionType": "Standard Deviation",
              "groups": [
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).",
                  "id": "OG000",
                  "title": "Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home"
                },
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).",
                  "id": "OG001",
                  "title": "Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital"
                }
              ],
              "paramType": "MEAN",
              "populationDescription": "mITTcross population included all randomized participants assigned into the cross-over period who received at least one dose of PH FDC SC, completed Question 1 of the PPQ and completed radiotherapy before entering the cross-over period.\nOverall number analyzed is the number of participants with data available for analysis.\nNumber analyzed is the number of participants with data available for analysis at the specified timepoint.",
              "reportingStatus": "POSTED",
              "reviewUnit": {
                "resetReasons": [
                  "The description of the scale or categories does not include sufficient information to understand the results reported."
                ]
              },
              "timeFrame": "Baseline (Cycle 1) of Run-in Period; Day 1 of Cycles 1, 3, and 6 in the Cross-over Period (Cycle length = 21 days)",
              "title": "Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores",
              "type": "SECONDARY",
              "unitOfMeasure": "score on a scale"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "90.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "64"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1a: Participant&#x27;s Home"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "72.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "9.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "64"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1a: Hospital Pharmacy"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "17.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "64"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1a: Day Oncology Unit"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "9.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "62"
                        },
                        {
                          "groupId": "OG001",
                          "value": "64"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1a: Other"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "11.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "77"
                        },
                        {
                          "groupId": "OG001",
                          "value": "77"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1c: Physician"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "35.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "77"
                        },
                        {
                          "groupId": "OG001",
                          "value": "77"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1c: Nurse"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "59.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "7.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "77"
                        },
                        {
                          "groupId": "OG001",
                          "value": "77"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1c: Pharmacist"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "77"
                        },
                        {
                          "groupId": "OG001",
                          "value": "77"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1c: All of Them"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "77"
                        },
                        {
                          "groupId": "OG001",
                          "value": "77"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1c: Other"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "95.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "63"
                        },
                        {
                          "groupId": "OG001",
                          "value": "67"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1a: Participant&#x27;s Home"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "4.8"
                        },
                        {
                          "groupId": "OG001",
                          "value": "71.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "63"
                        },
                        {
                          "groupId": "OG001",
                          "value": "67"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1a: Hospital Pharmacy"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "20.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "63"
                        },
                        {
                          "groupId": "OG001",
                          "value": "67"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6: Q1a: Day Oncology Unit"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "7.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "63"
                        },
                        {
                          "groupId": "OG001",
                          "value": "67"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1a: Other"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "5.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "72"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1c: Physician"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "88.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "29.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "72"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1c: Nurse"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "58.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "72"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1c: Pharmacist"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "72"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1c: All of them"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "72"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1c: Other"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "78"
                    },
                    {
                      "groupId": "OG001",
                      "value": "77"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with preparation and&#x2F;or administration of PH FDC SC completed the following questions of the HCPQ: Q1a: Where was the treatment prepared?\nQ1c: Which healthcare professionals were involved in the treatment preparation processes?\nThe 4 available response options for Q1a were: Participant&#x27;s home, Hospital pharmacy, Day oncology unit, or Other.\nThe 5 available response options for Q1c were: Physician, Nurse, Pharmacist, All of them or Other.\nPercentages were rounded off.",
              "groups": [
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).",
                  "id": "OG000",
                  "title": "Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home"
                },
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).",
                  "id": "OG001",
                  "title": "Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "Overall number analyzed is the number of HCPs who answered Q1a and Q1c of the HCPQ.\nNumber analyzed is the number of HCPs who answered Q1a and Q1c of the HCPQ at the specified timepoint.",
              "reportingStatus": "POSTED",
              "timeFrame": "Day 1 of Cycles 3 and 6 (Cycle length = 21 days)",
              "title": "Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of HCPs"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "1",
                          "upperLimit": "33",
                          "value": "5.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "1",
                          "upperLimit": "30",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "20"
                        },
                        {
                          "groupId": "OG001",
                          "value": "19"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1b(1)"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "0",
                          "upperLimit": "35",
                          "value": "5.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "0",
                          "upperLimit": "70",
                          "value": "1.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "16"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1b(2)"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "1",
                          "upperLimit": "30",
                          "value": "5.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "1",
                          "upperLimit": "15",
                          "value": "4.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "18"
                        },
                        {
                          "groupId": "OG001",
                          "value": "9"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1b(1)"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "0",
                          "upperLimit": "60",
                          "value": "0.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "0",
                          "upperLimit": "30",
                          "value": "3.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "15"
                        },
                        {
                          "groupId": "OG001",
                          "value": "7"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1b(2)"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "20"
                    },
                    {
                      "groupId": "OG001",
                      "value": "19"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with preparation and&#x2F;or administration of PH FDC SC completed the following parts of question Q1b: Q1b(1): How long did it take to prepare the treatment for use?\nQ1b(2): Time from the preparation place to reach the participant&#x27;s home.",
              "dispersionType": "Full Range",
              "groups": [
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).",
                  "id": "OG000",
                  "title": "Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home"
                },
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).",
                  "id": "OG001",
                  "title": "Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital"
                }
              ],
              "paramType": "MEDIAN",
              "populationDescription": "Overall number analyzed is the number of HCPs who answered Q1b of the HCPQ.\nNumber analyzed is the number of HCPs who answered Q1b of the HCPQ at the specified timepoint.",
              "reportingStatus": "POSTED",
              "timeFrame": "Day 1 of Cycles 3 and 6 (Cycle length = 21 days)",
              "title": "Adjuvant Cross-over Period: Duration of Treatment Preparation, According to HCPs&#x27; Responses to Question 1b of the HCPQ - Drug Preparation Area",
              "type": "SECONDARY",
              "unitOfMeasure": "minutes"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "18.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "16.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "43.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "21.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "38.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "37.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "9.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "4.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "24.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "13.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "13.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "33.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "18.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "35.8"
                        },
                        {
                          "groupId": "OG001",
                          "value": "35.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "9.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "18.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "21.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "39.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "16.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "38.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "37.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "11.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "59.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "22.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "79"
                        },
                        {
                          "groupId": "OG001",
                          "value": "72"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q3: Participant&#x27;s Home"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "36.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "79"
                        },
                        {
                          "groupId": "OG001",
                          "value": "72"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q3: In hospital"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "11.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "31.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "79"
                        },
                        {
                          "groupId": "OG001",
                          "value": "72"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q3: No Difference"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "26.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "9.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "79"
                        },
                        {
                          "groupId": "OG001",
                          "value": "72"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q3: Unsure"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "73.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "38.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "79"
                        },
                        {
                          "groupId": "OG001",
                          "value": "72"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q4: Participant&#x27;s Home"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "5.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "36.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "79"
                        },
                        {
                          "groupId": "OG001",
                          "value": "72"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q4: In hospital"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "8.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "19.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "79"
                        },
                        {
                          "groupId": "OG001",
                          "value": "72"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q4: No Difference"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "12.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "79"
                        },
                        {
                          "groupId": "OG001",
                          "value": "72"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q4: Unsure"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "81"
                    },
                    {
                      "groupId": "OG001",
                      "value": "75"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with preparation and&#x2F;or administration of PH FDC SC completed the questions 2, 3 and 4 of the HCPQ: Q2: If all PH FDC SC injections were switched from an in-hospital setting to the participant´s home, please indicate how strongly you agree or disagree with each of the following statements: 2a: Staff will have increased availability for other tasks in the hospital´s pharmacy.\n2b: Administrative procedures related to PH FDC SC will require less time.\n2c: Number of preparation steps and staff time commitment are reduced.\nThe 5 response options were: Strongly disagree, Disagree, Neutral, Agree, Strongly agree or Not applicable.\nQ3: Which took less time?\nQ4: Which required less use of institutional resources?\nThe 4 available options were: Participant&#x27;s home, In hospital, No difference, or Unsure.\nPercentages were rounded off.",
              "groups": [
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).",
                  "id": "OG000",
                  "title": "Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home"
                },
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).",
                  "id": "OG001",
                  "title": "Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "Overall number analyzed is the number of HCPs who answered any of the questions Q2, Q3, and Q4 of the HCPQ.\nNumber analyzed is the number of HCPs who answered each sub-question of Q2, and Q3, and Q4 of the HCPQ.",
              "reportingStatus": "POSTED",
              "timeFrame": "Day 1 of Cycle 6 (Cycle length = 21 days)",
              "title": "Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of HCPs"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "60",
                          "upperLimit": "105",
                          "value": "82.5"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "11",
                          "upperLimit": "540",
                          "value": "60.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "73"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1a"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "10",
                          "upperLimit": "420",
                          "value": "60.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "10",
                          "upperLimit": "660",
                          "value": "60.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "67"
                        },
                        {
                          "groupId": "OG001",
                          "value": "23"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1b"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "5",
                          "upperLimit": "13",
                          "value": "5.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "5",
                          "upperLimit": "30",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "75"
                        },
                        {
                          "groupId": "OG001",
                          "value": "76"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1c"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "5",
                          "upperLimit": "540",
                          "value": "30.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "5",
                          "upperLimit": "240",
                          "value": "75.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "75"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1d"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "25",
                          "upperLimit": "586",
                          "value": "120.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "70",
                          "upperLimit": "360",
                          "value": "180.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "73"
                        },
                        {
                          "groupId": "OG001",
                          "value": "14"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1e"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG001",
                          "lowerLimit": "40",
                          "upperLimit": "175",
                          "value": "90.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "69"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1f"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "5",
                          "upperLimit": "480",
                          "value": "65.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "50",
                          "upperLimit": "180",
                          "value": "85.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "80"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1a"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "15",
                          "upperLimit": "480",
                          "value": "60.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "5",
                          "upperLimit": "660",
                          "value": "60.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "35"
                        },
                        {
                          "groupId": "OG001",
                          "value": "71"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1b"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "5",
                          "upperLimit": "30",
                          "value": "5.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "5",
                          "upperLimit": "10",
                          "value": "5.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1c"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "8",
                          "upperLimit": "165",
                          "value": "90.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "5",
                          "upperLimit": "240",
                          "value": "30.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "73"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1d"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "50",
                          "upperLimit": "600",
                          "value": "120.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "25",
                          "upperLimit": "480",
                          "value": "120.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "27"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1e"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "20",
                          "upperLimit": "165",
                          "value": "90.0"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "90",
                          "upperLimit": "90",
                          "value": "90.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "79"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1f"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "81"
                    },
                    {
                      "groupId": "OG001",
                      "value": "76"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with the preparation and&#x2F;or administration of PH FDC SC completed the following questions of the HCPQ: Q1a: How long did it take to travel to the participant&#x27;s home to administer PH FDC SC? Q1b: How long did it take for the participant to travel to the hospital to receive PH FDC SC? Q1c: How long did it take to administer PH FDC SC? Q1d: How long was the participant treatment time?\nQ1e: How much time did the participant spend in hospital?\nQ1f: How much time did you spend at the participant&#x27;s home?\nFrom arrival to departure time.",
              "dispersionType": "Full Range",
              "groups": [
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).",
                  "id": "OG000",
                  "title": "Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home"
                },
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).",
                  "id": "OG001",
                  "title": "Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital"
                }
              ],
              "paramType": "MEDIAN",
              "populationDescription": "Overall number analyzed is the number of HCPs who answered Q1a to Q1f of the HCPQ.\nNumber analyzed is the number of HCPs who answered Q1a to Q1f of the HCPQ at the specified timepoint.",
              "reportingStatus": "POSTED",
              "timeFrame": "Day 1 of Cycles 3 and 6 (Cycle length = 21 days)",
              "title": "Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs&#x27; Responses to Question 1a to 1f of the HCPQ - Administering Treatment",
              "type": "SECONDARY",
              "unitOfMeasure": "minutes"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "35.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "14.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "45"
                        },
                        {
                          "groupId": "OG001",
                          "value": "55"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1g: Yes"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "64.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "85.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "45"
                        },
                        {
                          "groupId": "OG001",
                          "value": "55"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1g: No"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "7.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "28"
                        },
                        {
                          "groupId": "OG001",
                          "value": "47"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1h: After Surgery and Before Adjuvant Treatment"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "7.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "10.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "28"
                        },
                        {
                          "groupId": "OG001",
                          "value": "47"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1h: After Initiating Adjuvant Treatment"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "85.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "85.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "28"
                        },
                        {
                          "groupId": "OG001",
                          "value": "47"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1h: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "45.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "21.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "20"
                        },
                        {
                          "groupId": "OG001",
                          "value": "14"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1i: Local Protocol"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "10.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "14.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "20"
                        },
                        {
                          "groupId": "OG001",
                          "value": "14"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1i: Risk of Recurrence"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "25.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "14.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "20"
                        },
                        {
                          "groupId": "OG001",
                          "value": "14"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1i: Participant Preference"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "15.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "50.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "20"
                        },
                        {
                          "groupId": "OG001",
                          "value": "14"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1i: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "5.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "20"
                        },
                        {
                          "groupId": "OG001",
                          "value": "14"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 3 Day 1: Q1i: Other"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "23.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "23.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "59"
                        },
                        {
                          "groupId": "OG001",
                          "value": "61"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1g: Yes"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "76.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "77.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "59"
                        },
                        {
                          "groupId": "OG001",
                          "value": "61"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1g: No"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "10.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "48"
                        },
                        {
                          "groupId": "OG001",
                          "value": "47"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1h: After Surgery and Before Adjuvant Treatment"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "48"
                        },
                        {
                          "groupId": "OG001",
                          "value": "47"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1h: After Initiating Adjuvant Treatment"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "89.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "87.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "48"
                        },
                        {
                          "groupId": "OG001",
                          "value": "47"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1h: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "27.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "42.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "29"
                        },
                        {
                          "groupId": "OG001",
                          "value": "21"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1i: Local Protocol"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "3.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "29"
                        },
                        {
                          "groupId": "OG001",
                          "value": "21"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1i: Risk of Recurrence"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "13.8"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "29"
                        },
                        {
                          "groupId": "OG001",
                          "value": "21"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1i: Participant Preference"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "51.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "38.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "29"
                        },
                        {
                          "groupId": "OG001",
                          "value": "21"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1i: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "3.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "9.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "29"
                        },
                        {
                          "groupId": "OG001",
                          "value": "21"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Cycle 6 Day 1: Q1i: Other"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "59"
                    },
                    {
                      "groupId": "OG001",
                      "value": "61"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with the preparation and&#x2F;or administration of PH FDC SC completed the following questions of the HCPQ: Q1g.\nDoes the participant still have implanted IV access?\nThe 2 available responses were: Yes or No. Q1h: If question 1g was answered &#x27;No&#x27;, when was the IV access removed?\nThe 3 available responses were: After surgery and before initiating adjuvant treatment; After initiating adjuvant treatment, or Not applicable.\nQ1i: If question 1g was answered &#x27;Yes&#x27;, what is the main reason to keep the IV access?\nThe 5 available responses were: Local protocol; Risk of recurrence; Participant preference; Not applicable, or Other.\nPercentages were rounded off.",
              "groups": [
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).",
                  "id": "OG000",
                  "title": "Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home"
                },
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).",
                  "id": "OG001",
                  "title": "Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "Overall number analyzed is the number of HCPs who answered Q1g to Q1i of the HCPQ.\nNumber analyzed is the number of HCPs who answered Q1g to Q1i of the HCPQ at the specified timepoint.",
              "reportingStatus": "POSTED",
              "timeFrame": "Day 1 of Cycles 3 and 6 (Cycle length = 21 days)",
              "title": "Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of HCPs"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "10.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "27.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "28"
                        },
                        {
                          "groupId": "OG001",
                          "value": "37"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q1j: &lt;12 Months"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "28.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "16.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "28"
                        },
                        {
                          "groupId": "OG001",
                          "value": "37"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q1j: ≥12 Months"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "14.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "16.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "28"
                        },
                        {
                          "groupId": "OG001",
                          "value": "37"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q1j: 18 Months"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "3.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "8.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "28"
                        },
                        {
                          "groupId": "OG001",
                          "value": "37"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q1j: &lt;24 Months"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "42.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "32.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "28"
                        },
                        {
                          "groupId": "OG001",
                          "value": "37"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q1j: ≥24 Months"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "44"
                        },
                        {
                          "groupId": "OG001",
                          "value": "39"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q1k: Before Surgery"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "10.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "44"
                        },
                        {
                          "groupId": "OG001",
                          "value": "39"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q1k: After Surgery"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "15.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "20.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "44"
                        },
                        {
                          "groupId": "OG001",
                          "value": "39"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q1k: After PCR Results"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "15.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "28.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "44"
                        },
                        {
                          "groupId": "OG001",
                          "value": "39"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q1k: After Completion of Full Adjuvant Therapy"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "29.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5.1"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "44"
                        },
                        {
                          "groupId": "OG001",
                          "value": "39"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q1k: After Completion of IV Antineoplastic Within Adjuvant Therapy"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "36.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "33.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "44"
                        },
                        {
                          "groupId": "OG001",
                          "value": "39"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q1k: Other"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "11.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "37.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "42"
                        },
                        {
                          "groupId": "OG001",
                          "value": "43"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q1l: Yes"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "35.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "37.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "42"
                        },
                        {
                          "groupId": "OG001",
                          "value": "43"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q1l: No"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "52.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "25.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "42"
                        },
                        {
                          "groupId": "OG001",
                          "value": "43"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q1l: Unsure"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "44"
                    },
                    {
                      "groupId": "OG001",
                      "value": "43"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "HCPs who have had experience with the preparation and&#x2F;or administration of PH FDC SC completed the following questions of the HCPQ: Q1j: How long do you keep implanted IV access in early human epidermal growth factor receptor 2 (HER2)-positive breast cancer participants with pCR following surgery in your institution?\nThe 5 available responses were: &lt;12 months, ≥12 months, 18 months, &lt;24 months, ≥24 months.\nQ1k: When is the decision point for you to decide to remove IV access for early HER2+ breast cancer participants?\nThe 6 available responses were: Before surgery, After surgery, After PCR results, After completion of full adjuvant therapy, After completion of IV antineoplastic within adjuvant therapy, and Other.\nQ1l: Do you consider it necessary to keep implanted IV access knowing that the participant&#x27;s treatment will be SC until the full 18 cycles?\nThe 3 available responses were: Yes, No, and Other.\nPercentages were rounded off.",
              "groups": [
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).",
                  "id": "OG000",
                  "title": "Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home"
                },
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).",
                  "id": "OG001",
                  "title": "Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "Overall number analyzed is the number of HCPs who answered any of the questions from Q1j to Q1l of the HCPQ.\nNumber analyzed is the number of HCPs who answered each specific question (Q1j to Q1l) of the HCPQ.",
              "reportingStatus": "POSTED",
              "timeFrame": "Day 1 of Cycle 6 (Cycle length = 21 days)",
              "title": "Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of HCPs"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "79"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "79"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "8.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "79"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "30.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "41.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "79"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "55.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "45.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "79"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "79"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2a: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "7.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "29.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "33.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "55.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "49.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2b: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "7.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5.3"
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                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "33.3"
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                        {
                          "groupId": "OG001",
                          "value": "33.3"
                        }
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                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
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                      "units": "Participants"
                    }
                  ],
                  "title": "Q2c: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "57.7"
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                        {
                          "groupId": "OG001",
                          "value": "53.3"
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                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
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                  "title": "Q2c: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4.0"
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                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
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                      "units": "Participants"
                    }
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                  "title": "Q2c: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
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                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "77"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
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                  "title": "Q2d: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "3.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "9.3"
                        }
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                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "77"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
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                      "units": "Participants"
                    }
                  ],
                  "title": "Q2d: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "14.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "14.7"
                        }
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                    }
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                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "77"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2d: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "27.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "25.3"
                        }
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                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "77"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2d: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "46.8"
                        },
                        {
                          "groupId": "OG001",
                          "value": "42.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "77"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2d: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "8.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "77"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2d: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
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                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
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                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2e: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.7"
                        }
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                  "denoms": [
                    {
                      "counts": [
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                          "value": "78"
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                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
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                  "title": "Q2e: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "19.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "20.0"
                        }
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                    {
                      "counts": [
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                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2e: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "26.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "33.3"
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                    {
                      "counts": [
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                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2e: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "43.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "33.3"
                        }
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                  "denoms": [
                    {
                      "counts": [
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                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2e: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "10.7"
                        }
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                    }
                  ],
                  "denoms": [
                    {
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                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2e: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "7.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
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                  "denoms": [
                    {
                      "counts": [
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                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.6"
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                        {
                          "groupId": "OG001",
                          "value": "4.0"
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                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "9.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "25.3"
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                  ],
                  "denoms": [
                    {
                      "counts": [
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                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "32.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "22.7"
                        }
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                  ],
                  "denoms": [
                    {
                      "counts": [
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                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "47.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "40.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
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                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "8.0"
                        }
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                  ],
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                    {
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                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2f: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
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                  ],
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                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
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                          "value": "1.3"
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                    {
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                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.7"
                        }
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                    {
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                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "24.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "32.0"
                        }
                      ]
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                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "67.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "56.0"
                        }
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                  "denoms": [
                    {
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                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4.0"
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                  "denoms": [
                    {
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                          "groupId": "OG000",
                          "value": "78"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2g: Not Applicable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.7"
                        }
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                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2h: Strongly Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "3.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "18.7"
                        }
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                    }
                  ],
                  "denoms": [
                    {
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                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2h: Disagree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "15.6"
                        },
                        {
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                          "value": "28.0"
                        }
                      ]
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                  "denoms": [
                    {
                      "counts": [
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                          "value": "77"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2h: Neutral"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "23.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "17.3"
                        }
                      ]
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                  ],
                  "denoms": [
                    {
                      "counts": [
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                          "value": "77"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2h: Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "49.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "29.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "77"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2h: Strongly Agree"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "77"
                        },
                        {
                          "groupId": "OG001",
                          "value": "75"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q2h: Not Applicable"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "79"
                    },
                    {
                      "groupId": "OG001",
                      "value": "75"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "HCPs who have had experience with the preparation and&#x2F;or administration of PH FDC SC completed the following question of the HCPQ: Q2: If all PH FDC SC injections were switched from an in-hospital setting to the participant&#x27;s home, please indicate how strongly you agree&#x2F;disagree with each of the following statements: 2a: PH FDC SC&#x27;s SC route of administration allows for more flexible treatment scheduling.\n2b: Frees up infusion chairs or outpatient procedure rooms used to administer SC injections.\n2c: Waiting list for infusion chairs or outpatient procedure rooms is reduced.\n2d: Staff&#x27;s work burden is reduced, enhancing work performance.\n2e: More interaction time between HCPs and participants on IV treatment.\n2f: Staff has more time for administrative tasks.\n2g: Participants will spend less time in hospital.\n2h: Participants prefer PH FDC SC at home.\nThe 6 available responses were: Strongly disagree, Disagree, Neutral, Agree, Strongly agree, &amp; Not applicable.",
              "groups": [
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).",
                  "id": "OG000",
                  "title": "Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home"
                },
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).",
                  "id": "OG001",
                  "title": "Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "Overall number analyzed is the number of HCPs who answered Q2 of the HCPQ.\nNumber analyzed is the number of HCPs who answered each sub-question of Q2 (Q2a-Q2h) of the HCPQ.\nPercentages were rounded off.",
              "reportingStatus": "POSTED",
              "timeFrame": "Day 1 of Cycle 6 (Cycle length = 21 days)",
              "title": "Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of HCPs"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "84.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "45.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q3: Participant&#x27;s Home"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "7.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "40.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q3: In Hospital"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q3: No Difference"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q3: Unsure"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "80.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "28.4"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q4: Participant&#x27;s Home"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "7.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "52.7"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q4: In Hospital"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "12.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q4: No Difference"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q4: Unsure"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "67.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "40.5"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q5: Participant&#x27;s Home"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "27.0"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q5: In Hospital"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "17.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "16.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q5: No Difference"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "8.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "16.2"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q5: Unsure"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "79.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "41.9"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q6: Participant&#x27;s Home"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "11.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "44.6"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q6: In Hospital"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q6: No Difference"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "3.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "6.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "74"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q6: Unsure"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "80.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "43.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "73"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q7: Always"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "17.3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "43.8"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "73"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q7: Sometimes"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "12.3"
                        }
                      ]
                    }
                  ],
                  "denoms": [
                    {
                      "counts": [
                        {
                          "groupId": "OG000",
                          "value": "81"
                        },
                        {
                          "groupId": "OG001",
                          "value": "73"
                        }
                      ],
                      "units": "Participants"
                    }
                  ],
                  "title": "Q7: Never"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "81"
                    },
                    {
                      "groupId": "OG001",
                      "value": "74"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "HCP was defined as any personnel involved in the drug preparation and&#x2F;or drug administration processes.\nHCPs who have had experience with the preparation and&#x2F;or administration of PH FDC SC completed the following questions of the HCPQ: Q3: Which was more convenient for the participant?\nQ4: Which was better for optimising participant care?\nQ5: Which required less use of institutional resources?\nQ6: Which was preferred by participants?\nThe 4 responses available were: Participant&#x27;s home, In hospital, No difference, and Unsure.\nQ7: How frequently would you recommend PH FDC SC at home to your participants in the future?\nThe 3 responses available were: Always, Sometimes, and Never.\nPercentages were rounded off.",
              "groups": [
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).",
                  "id": "OG000",
                  "title": "Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home"
                },
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).",
                  "id": "OG001",
                  "title": "Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "Overall number analyzed is the number of HCPs who answered any of the questions from Q3 to Q7 of the HCPQ.\nNumber analyzed is the number of HCPs who answered each specific question (Q3 to Q7) of the HCPQ.",
              "reportingStatus": "POSTED",
              "timeFrame": "Day 1 of Cycle 6 (Cycle length = 21 days)",
              "title": "Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of HCPs"
            },
            {
              "denomUnitsSelected": "Participants",
              "description": "EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions used to assess the HRQoL in cancer participants.\nFirst 28 questions evaluates 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).\nThese questions used a 4-point scale, with scores ranging from 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much).\nThe last 2 questions represents the participant&#x27;s assessment of GHS&#x2F;QoL, using a 7-point scale with scores ranging from 0-7 (1=very poor to 7=excellent).\nEORTC QLQ-C30 scores will be linearly transformed on a scale of 0 - 100, with a high score indicating better GHS&#x2F;QOL.\nNegative change from Baseline values indicates deterioration in QOL or functioning and positive values indicates improvement.",
              "reportingStatus": "NOT_POSTED",
              "timeFrame": "Day 1 of Cycles 1 and 6 (1 Cycle = 21 days)",
              "title": "Adjuvant Phase: HRQoL Assessed by EORTC QLQ C30 Scores in Participants Treated With Trastuzumab Emtansine IV",
              "type": "SECONDARY"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "68.8"
                        },
                        {
                          "groupId": "OG001",
                          "value": "54.3"
                        }
                      ]
                    }
                  ],
                  "title": "Choice of Home Setting"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "31.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "45.7"
                        }
                      ]
                    }
                  ],
                  "title": "Choice of Hospital Setting"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "96"
                    },
                    {
                      "groupId": "OG001",
                      "value": "92"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "The percentage of participants who chose to receive PH FDC SC in the home setting or in the hospital setting during the treatment continuation period is reported.",
              "groups": [
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).",
                  "id": "OG000",
                  "title": "Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home"
                },
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).",
                  "id": "OG001",
                  "title": "Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "The analysis includes all randomized participants assigned into the cross-over period who received at least one dose of PH FDC SC and entered the treatment continuation phase.",
              "reportingStatus": "POSTED",
              "timeFrame": "Upon completion of adjuvant cross-over period (Day 1 of Cycle 8 or 9; Cycle length = 21 days)",
              "title": "Percentage of Participants Who Selected the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in the Treatment Continuation Period",
              "type": "SECONDARY",
              "unitOfMeasure": "Percentage of participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "113"
                        },
                        {
                          "groupId": "OG001",
                          "value": "227"
                        }
                      ]
                    }
                  ],
                  "title": "AEs"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "19"
                        },
                        {
                          "groupId": "OG001",
                          "value": "43"
                        }
                      ]
                    }
                  ],
                  "title": "SAEs"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "46"
                        },
                        {
                          "groupId": "OG001",
                          "value": "103"
                        }
                      ]
                    }
                  ],
                  "title": "Grade ≥ 3 AEs"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3"
                        }
                      ]
                    }
                  ],
                  "title": "Cardiac AEs"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "115"
                    },
                    {
                      "groupId": "OG001",
                      "value": "228"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with use of a study treatment, whether or not considered related to the study treatment.\nSAE=any untoward medical occurrence that, at any dose: Results in death; Is life threatening; Requires inpatient hospitalization&#x2F;prolongation of existing hospitalization; Results in persistent disability&#x2F;incapacity &amp;&#x2F;or is a congenital anomaly&#x2F;birth defect.\nCardiac AEs=asymptomatic decline in left ventricular ejection fraction (LVEF) of ≥10% from baseline to an LVEF &lt;50%; asymptomatic decline in LVEF requiring treatment&#x2F;leading to discontinuation of study treatment; congestive heart failure (CHF).\nAEs ≥Grade 3=marked limitation of physical activity.\nComfortable at rest, but any ordinary activity causes fatigue, palpitation&#x2F;dyspnea; Inability to carry any physical activity without discomfort.\nSymptoms of cardiac insufficiency at rest.\nAny physical activity leads to discomfort.",
              "groups": [
                {
                  "description": "Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg&#x2F;kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg&#x2F;kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG000",
                  "title": "Arm A, Neoadjuvant Phase: P+H IV"
                },
                {
                  "description": "Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG001",
                  "title": "Arm B, Neoadjuvant Phase: PH FDC SC"
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "populationDescription": "Neoadjuvant safety analysis set (SASab) included all randomized participants who received at least one study treatment during the neoadjuvant phase.",
              "reportingStatus": "POSTED",
              "timeFrame": "From initiation of study treatment until 28 days after the last treatment cycle (up to approximately 7.4 months)",
              "title": "Neoadjuvant Phase: Number of Participants With Adverse Events (AEs), Grade ≥ 3 AEs, Serious AEs (SAEs), and Cardiac AEs",
              "type": "SECONDARY",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "8"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "115"
                    },
                    {
                      "groupId": "OG001",
                      "value": "228"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment.\nAn AE can therefore be any unfavorable &amp; unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study intervention.\nParticipants who discontinued the study due to AEs are reported here.",
              "groups": [
                {
                  "description": "Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg&#x2F;kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg&#x2F;kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG000",
                  "title": "Arm A, Neoadjuvant Phase: P+H IV"
                },
                {
                  "description": "Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
                  "id": "OG001",
                  "title": "Arm B, Neoadjuvant Phase: PH FDC SC"
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "populationDescription": "SASab included all randomized participants who received at least one study treatment during the neoadjuvant phase.",
              "reportingStatus": "POSTED",
              "timeFrame": "Up to Cycle 8 (1 Cycle = 21 days)",
              "title": "Neoadjuvant Phase: Number of Participants With Premature Withdrawal From PH FDC SC and P+H IV Due to AEs",
              "type": "SECONDARY",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "99"
                        },
                        {
                          "groupId": "OG001",
                          "value": "89"
                        }
                      ]
                    }
                  ],
                  "title": "AEs"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "SAEs"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2"
                        }
                      ]
                    }
                  ],
                  "title": "Cardiac AEs"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3"
                        }
                      ]
                    }
                  ],
                  "title": "Grade ≥3 AEs"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "190"
                    },
                    {
                      "groupId": "OG001",
                      "value": "191"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with use of a study treatment, whether or not considered related to the study treatment.\nSAE=any untoward medical occurrence that, at any dose: Results in death; Is life threatening; Requires inpatient hospitalization&#x2F;prolongation of existing hospitalization; Results in persistent disability&#x2F;incapacity &amp;&#x2F;or is a congenital anomaly&#x2F;birth defect.\nCardiac AEs=asymptomatic decline in LVEF of ≥10% from baseline to an LVEF &lt;50%; asymptomatic decline in LVEF requiring treatment&#x2F;leading to discontinuation of study treatment; CHF.\nAEs ≥Grade 3=marked limitation of physical activity.\nComfortable at rest, but any ordinary activity causes fatigue, palpitation&#x2F;dyspnea; Inability to carry any physical activity without discomfort.\nSymptoms of cardiac insufficiency at rest.\nAny physical activity leads to discomfort.",
              "groups": [
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).",
                  "id": "OG000",
                  "title": "Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home"
                },
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).",
                  "id": "OG001",
                  "title": "Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital"
                }
              ],
              "measureCategoriesReviewUnit": {
                "resetReasons": [
                  "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
                ]
              },
              "paramType": "COUNT_OF_PARTICIPANTS",
              "populationDescription": "Adjuvant safety analysis set (SAScd+) included all participants with pCR who received at least one dose of PH FDC SC during the adjuvant phase.",
              "reportingStatus": "POSTED",
              "timeFrame": "From initiation of study treatment until 28 days after the last treatment cycle (up to approximately 5.8 months)",
              "title": "Adjuvant Cross-over Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs",
              "type": "SECONDARY",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "190"
                    },
                    {
                      "groupId": "OG001",
                      "value": "191"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment.\nAn AE can therefore be any unfavorable &amp; unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study intervention.\nParticipants who discontinued the study due to AEs are reported here.",
              "groups": [
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).",
                  "id": "OG000",
                  "title": "Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home"
                },
                {
                  "description": "Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).",
                  "id": "OG001",
                  "title": "Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital"
                }
              ],
              "measureCategoriesReviewUnit": {
                "resetReasons": [
                  "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
                ]
              },
              "paramType": "COUNT_OF_PARTICIPANTS",
              "populationDescription": "SAScd+ included all participants with pCR who received at least one dose of PH FDC SC during the adjuvant phase.",
              "reportingStatus": "POSTED",
              "timeFrame": "Up to Cycle 6 (Cycle length = 21 days)",
              "title": "Adjuvant Cross-over Period: Number of Participants With Premature Withdrawal From PH FDC SC Due to AEs",
              "type": "SECONDARY",
              "unitOfMeasure": "Participants"
            },
            {
              "denomUnitsSelected": "Participants",
              "description": "AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with use of a study treatment, whether or not considered related to the study treatment.\nSAE=any untoward medical occurrence that, at any dose: Results in death; Is life threatening; Requires inpatient hospitalization&#x2F;prolongation of existing hospitalization; Results in persistent disability&#x2F;incapacity &amp;&#x2F;or is a congenital anomaly&#x2F;birth defect.\nCardiac AEs=asymptomatic decline in LVEF of ≥10% from baseline to an LVEF &lt;50%; asymptomatic decline in LVEF requiring treatment&#x2F;leading to discontinuation of study treatment; CHF.\nAEs ≥Grade 3=marked limitation of physical activity.\nComfortable at rest, but any ordinary activity causes fatigue, palpitation&#x2F;dyspnea; Inability to carry any physical activity without discomfort.\nSymptoms of cardiac insufficiency at rest.\nAny physical activity leads to discomfort.",
              "reportingStatus": "NOT_POSTED",
              "timeFrame": "From initiation of study treatment until 28 days after the last treatment cycle (up to approximately 3.5 years)",
              "title": "Treatment Continuation Period and Trastuzumab Emtansine IV Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs",
              "type": "SECONDARY"
            },
            {
              "denomUnitsSelected": "Participants",
              "description": "An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment.\nAn AE can therefore be any unfavorable &amp; unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study intervention.\nParticipants who discontinue study due to AEs will be reported.",
              "reportingStatus": "NOT_POSTED",
              "timeFrame": "From initiation of study treatment in the adjuvant phase until 28 days after the last treatment cycle (up to approximately 3.5 years)",
              "title": "Treatment Continuation Period and Trastuzumab Emtansine IV Period: Number of Participants With Premature Withdrawal From PH FDC SC and Trastuzumab Emtansine IV Due to AEs",
              "type": "SECONDARY"
            }
          ]
        },
        "participantFlowModule": {
          "groups": [
            {
              "description": "Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg&#x2F;kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg&#x2F;kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
              "id": "FG000",
              "title": "Arm A, Neoadjuvant Phase: P+H IV"
            },
            {
              "description": "Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator&#x27;s choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).",
              "id": "FG001",
              "title": "Arm B, Neoadjuvant Phase: PH FDC SC"
            },
            {
              "description": "Participants who achieved pathologic complete response (pCR) after surgery received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and rHuPH20, 30,000 U, as a SC injection on Day 1 of Cycle 1 followed by maintenance dose of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, on Day 1 of Cycle 2 (Cycle length = 21 days).",
              "id": "FG002",
              "title": "Adjuvant Run-in Phase: PH FDC SC in Hospital"
            },
            {
              "description": "Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).",
              "id": "FG003",
              "title": "Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home"
            },
            {
              "description": "Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).",
              "id": "FG004",
              "title": "Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital"
            },
            {
              "description": "Participants randomized to Arm C and who completed the cross-over period had an option to receive further treatment in either the home or hospital setting with maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection up to a maximum of 18 cycles (Cycle length = 21 days).",
              "id": "FG005",
              "title": "Arm C, Adjuvant Continuation Phase: PH FDC SC"
            },
            {
              "description": "Participants randomized to Arm D and who completed the cross-over period had an option to receive further treatment in either the home or hospital setting received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection up to a maximum of 18 cycles (Cycle length = 21 days).",
              "id": "FG006",
              "title": "Arm D, Adjuvant Continuation Phase: PH FDC SC"
            },
            {
              "description": "Participants who did not achieve pCR after surgery received trastuzumab emtansine, 3.6 mg&#x2F;kg, as an IV infusion for 90 minutes as an initial dose.\nThereafter, participants received trastuzumab emtansine, 3.6 mg&#x2F;kg, as an IV infusion for 30 minutes, Q3W for 14 cycles (Cycle length = 21 days).",
              "id": "FG007",
              "title": "Arm E, Adjuvant Phase: Trastuzumab Emtansine IV"
            }
          ],
          "periods": [
            {
              "dropWithdraws": [
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "8"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Adverse Event"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "4"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Death"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "2"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "11"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Withdrawal by Subject"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "2"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Progressive Disease"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "1"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "4"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Reason not Specified"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "1"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "1"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Treatment Intolerance"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "1"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "1"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Lost to Follow-up"
                }
              ],
              "milestones": [
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "116"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "231"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "STARTED"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "115"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "228"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "comment": "SASab included all randomized participants who received at least one study treatment during the neoadjuvant phase.",
                  "type": "Neoadjuvant Safety Analysis Set (SASab)"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "114"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "210"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Completed Neoadjuvant Treatment"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "113"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "207"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Completed Surgery"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "68"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "126"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Continued Into the Run-in Period"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "43"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "74"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Continued Into Trastuzumab Emtansine IV Arm"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "111"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "200"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "comment": "Completed Neoadjuvant Treatment and Surgery and Continued to Adjuvant Phase",
                  "type": "COMPLETED"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "5"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "31"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "NOT COMPLETED"
                }
              ],
              "title": "Neoadjuvant Phase"
            },
            {
              "milestones": [
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "0"
                    },
                    {
                      "comment": "All participants that achieved pCR without discontinuing after surgery.",
                      "groupId": "FG002",
                      "numSubjects": "194"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
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                    },
                    {
                      "groupId": "FG005",
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                    },
                    {
                      "groupId": "FG006",
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                    },
                    {
                      "groupId": "FG007",
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                    }
                  ],
                  "comment": "Received ≥1 Dose of Adjuvant Run-in Treatment",
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                },
                {
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                    {
                      "groupId": "FG000",
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                    },
                    {
                      "groupId": "FG001",
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                    },
                    {
                      "groupId": "FG002",
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                    },
                    {
                      "groupId": "FG003",
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                    },
                    {
                      "groupId": "FG004",
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                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
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                  "type": "COMPLETED"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG001",
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                    },
                    {
                      "groupId": "FG002",
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                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "NOT COMPLETED"
                }
              ],
              "title": "Adjuvant Phase: Run-in Period"
            },
            {
              "dropWithdraws": [
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
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                    {
                      "groupId": "FG001",
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                    {
                      "groupId": "FG002",
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                    {
                      "groupId": "FG003",
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                    {
                      "groupId": "FG004",
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                    {
                      "groupId": "FG005",
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                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Adverse Event"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
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                      "groupId": "FG001",
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                    {
                      "groupId": "FG002",
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                    {
                      "groupId": "FG003",
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                    {
                      "groupId": "FG005",
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                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
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                  ],
                  "type": "Withdrawal by Subject"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
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                    {
                      "groupId": "FG001",
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                    {
                      "groupId": "FG002",
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                    },
                    {
                      "groupId": "FG003",
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                      "groupId": "FG004",
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                    {
                      "groupId": "FG005",
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                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Treatment Intolerance"
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              ],
              "milestones": [
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "comment": "1 participant was randomized but didn&#x27;t receive any treatment.",
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                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "96"
                    },
                    {
                      "groupId": "FG005",
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                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
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                  ],
                  "comment": "Randomized to Adjuvant Cross-Over Treatment Arms",
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                {
                  "achievements": [
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                      "groupId": "FG000",
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                    {
                      "groupId": "FG001",
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                    {
                      "groupId": "FG002",
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                    {
                      "groupId": "FG003",
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                    },
                    {
                      "groupId": "FG004",
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                    },
                    {
                      "groupId": "FG005",
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                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Received ≥1 Dose of Adjuvant Cross-Over Treatment"
                },
                {
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                      "groupId": "FG000",
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                    {
                      "groupId": "FG001",
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                    {
                      "groupId": "FG002",
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                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "96"
                    },
                    {
                      "groupId": "FG004",
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                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
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                    },
                    {
                      "groupId": "FG007",
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                  ],
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                },
                {
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                    {
                      "groupId": "FG001",
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                    {
                      "groupId": "FG002",
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                    {
                      "groupId": "FG003",
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                    {
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                    {
                      "groupId": "FG005",
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                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "NOT COMPLETED"
                }
              ],
              "title": "Adjuvant Phase: Cross-over Period"
            },
            {
              "dropWithdraws": [
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
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                    {
                      "groupId": "FG001",
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                    },
                    {
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                    {
                      "groupId": "FG003",
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                    },
                    {
                      "groupId": "FG004",
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                    {
                      "groupId": "FG005",
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                      "groupId": "FG006",
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                    {
                      "groupId": "FG007",
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                  ],
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                {
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                      "groupId": "FG000",
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                    {
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                    {
                      "groupId": "FG003",
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                    {
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                    {
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                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Non-compliance With Study Drug"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
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                    {
                      "groupId": "FG001",
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                    {
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                    {
                      "groupId": "FG003",
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                    {
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                    {
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                    {
                      "groupId": "FG007",
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                  ],
                  "type": "Withdrawal by Subject"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
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                    {
                      "groupId": "FG001",
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                    {
                      "groupId": "FG002",
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                    },
                    {
                      "groupId": "FG003",
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                    },
                    {
                      "groupId": "FG004",
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                    {
                      "groupId": "FG006",
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                    },
                    {
                      "groupId": "FG007",
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                  ],
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                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
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                    {
                      "groupId": "FG001",
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                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "1"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Reason not Specified"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG001",
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                    },
                    {
                      "groupId": "FG002",
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                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
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                    },
                    {
                      "groupId": "FG005",
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                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "9"
                    },
                    {
                      "groupId": "FG007",
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                    }
                  ],
                  "type": "Ongoing in Treatment"
                }
              ],
              "milestones": [
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                      "groupId": "FG000",
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                    {
                      "groupId": "FG001",
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                    },
                    {
                      "groupId": "FG002",
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                    },
                    {
                      "groupId": "FG003",
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                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG005",
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                    },
                    {
                      "comment": "1 participant discontinued after having completed cross-over treatment, and proceeded to follow-up and study completion.",
                      "groupId": "FG006",
                      "numSubjects": "93"
                    },
                    {
                      "groupId": "FG007",
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                  ],
                  "type": "STARTED"
                },
                {
                  "achievements": [
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                      "groupId": "FG000",
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                    {
                      "groupId": "FG001",
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                      "groupId": "FG002",
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                    {
                      "groupId": "FG003",
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                    },
                    {
                      "groupId": "FG004",
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                    {
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                    {
                      "groupId": "FG006",
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                    },
                    {
                      "groupId": "FG007",
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                    }
                  ],
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                },
                {
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                      "groupId": "FG000",
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                    },
                    {
                      "groupId": "FG001",
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                    },
                    {
                      "groupId": "FG002",
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                    },
                    {
                      "groupId": "FG003",
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                    },
                    {
                      "groupId": "FG004",
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                    },
                    {
                      "groupId": "FG005",
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                    },
                    {
                      "groupId": "FG006",
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                    },
                    {
                      "groupId": "FG007",
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                    }
                  ],
                  "type": "Chose Hospital Setting for Continuation Treatment"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
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                    },
                    {
                      "groupId": "FG001",
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                    },
                    {
                      "groupId": "FG002",
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                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
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                    },
                    {
                      "groupId": "FG005",
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                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "89"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Received ≥1 Dose of Continuation Treatment"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
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                    },
                    {
                      "groupId": "FG001",
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                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
                      "numSubjects": "0"
                    },
                    {
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                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "81"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "comment": "Completed Adjuvant Continuation Treatment",
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                },
                {
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                      "groupId": "FG000",
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                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG004",
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                    },
                    {
                      "groupId": "FG005",
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                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "12"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "NOT COMPLETED"
                }
              ],
              "title": "Adjuvant Phase: Continuation Period"
            },
            {
              "dropWithdraws": [
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG001",
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                    },
                    {
                      "groupId": "FG002",
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                    },
                    {
                      "groupId": "FG003",
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                    },
                    {
                      "groupId": "FG004",
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                    },
                    {
                      "groupId": "FG005",
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                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
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                    }
                  ],
                  "type": "Adverse Event"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
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                    },
                    {
                      "groupId": "FG001",
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                    },
                    {
                      "groupId": "FG002",
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                    },
                    {
                      "groupId": "FG003",
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                    },
                    {
                      "groupId": "FG004",
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                    {
                      "groupId": "FG005",
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                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
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                  ],
                  "type": "Death"
                },
                {
                  "reasons": [
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                      "groupId": "FG000",
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                    {
                      "groupId": "FG001",
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                    {
                      "groupId": "FG003",
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                    },
                    {
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                    {
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                    {
                      "groupId": "FG006",
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                    },
                    {
                      "groupId": "FG007",
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                    }
                  ],
                  "type": "Withdrawal by Subject"
                },
                {
                  "reasons": [
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                    {
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                    },
                    {
                      "groupId": "FG003",
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                    },
                    {
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                    },
                    {
                      "groupId": "FG005",
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                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "1"
                    }
                  ],
                  "type": "Physician Decision"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
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                    },
                    {
                      "groupId": "FG001",
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                    },
                    {
                      "groupId": "FG002",
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                    },
                    {
                      "groupId": "FG003",
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                    },
                    {
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                    },
                    {
                      "groupId": "FG005",
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                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "2"
                    }
                  ],
                  "type": "Reason not Specified"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG001",
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                    },
                    {
                      "groupId": "FG002",
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                    },
                    {
                      "groupId": "FG003",
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                    },
                    {
                      "groupId": "FG004",
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                    },
                    {
                      "groupId": "FG005",
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                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "4"
                    }
                  ],
                  "type": "Treatment intolerance"
                },
                {
                  "reasons": [
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                      "groupId": "FG000",
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                    },
                    {
                      "groupId": "FG001",
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                    },
                    {
                      "groupId": "FG002",
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                    },
                    {
                      "groupId": "FG003",
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                    },
                    {
                      "groupId": "FG004",
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                    },
                    {
                      "groupId": "FG005",
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                    },
                    {
                      "groupId": "FG006",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG007",
                      "numSubjects": "25"
                    }
                  ],
                  "type": "Ongoing in Treatment"
                }
              ],
              "milestones": [
                {
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                      "groupId": "FG000",
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                    },
                    {
                      "groupId": "FG001",
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                    },
                    {
                      "groupId": "FG002",
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                    },
                    {
                      "groupId": "FG003",
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                    },
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