evt_NCT05415215_v30_v31_8a5b416dc630

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/8/reviewUnit",
    "/protocolSection/outcomesModule/secondaryOutcomes/9/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/9/reviewUnit",
    "/protocolSection/outcomesModule/secondaryOutcomes/10/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/10/reviewUnit",
    "/protocolSection/outcomesModule/secondaryOutcomes/16/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/19/description",
    "/protocolSection/contactsLocationsModule/locations/0/facility",
    "/protocolSection/contactsLocationsModule/locations/0/zip",
    "/protocolSection/contactsLocationsModule/locations/0/state",
    "/resultsSection/participantFlowModule/periods/0/milestones/6",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/measureCategoriesReviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/populationDescription",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/measureCategoriesReviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/10/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/10/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/11/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/11/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/17/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/20/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/24/populationDescription",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/24/groups/0/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/24/groups/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/24/groups/1/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/24/groups/1/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/24/measureCategoriesReviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/25/populationDescription",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/25/groups/0/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/25/groups/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/25/groups/1/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/25/groups/1/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/25/measureCategoriesReviewUnit",
    "/annotationSection"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT05415215_v30_v31_8a5b416dc630. ClinicalTrials.gov NCT05415215, versions 30-31. 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 30 to version 31 for NCT05415215.",
    "The JSON Patch for this comparison has hash 892b75be997beb5225cd295dd135b61bdb49ea821ae8f031e8b3a07285914fb6.",
    "The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.",
    "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.",
    "The timing context for the from-version record was post_recruitment.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/8/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/9/description, /protocolSection/outcomesModule/secondaryOutcomes/9/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/10/description, /protocolSection/outcomesModule/secondaryOutcomes/10/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/16/description, /protocolSection/outcomesModule/secondaryOutcomes/19/description, /protocolSection/contactsLocationsModule/locations/0/facility, /protocolSection/contactsLocationsModule/locations/0/zip, /protocolSection/contactsLocationsModule/locations/0/state, /resultsSection/participantFlowModule/periods/0/milestones/6, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/9/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/9/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/10/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/10/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/11/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/11/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/17/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/20/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/24/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/24/groups/0/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/24/groups/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/24/groups/1/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/24/groups/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/24/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/25/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/25/groups/0/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/25/groups/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/25/groups/1/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/25/groups/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/25/measureCategoriesReviewUnit, /annotationSection.",
    "An outcome path changed between versions 30 and 31 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "results_reconciliation"
    ],
    "category": "results_reconciliation",
    "deterministic_rules": [],
    "event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting"
    ],
    "rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
    "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/secondaryOutcomes/10/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/10/reviewUnit",
          "/protocolSection/outcomesModule/secondaryOutcomes/16/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/19/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/8/reviewUnit",
          "/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/9/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/9/reviewUnit"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT05415215_v30_v31_8a5b416dc630",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2025-12"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2025-12-18"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2026-01-12"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
      "value": "2025-12-18"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
      "value": {
        "date": "2026-01-12",
        "type": "ACTUAL"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame",
      "value": "Up to approximately 7.8 months"
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/8/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/9/description",
      "value": "EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting & pain), global health status/quality of life (GHS/QoL) & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).\nFunctioning & symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much.\nGHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent.\nAll EORTC scales & single-item measures were linearly transformed to a score range of 0-100.\nHigh score for functional/GHS scale=high/healthy level of functioning/better HRQoL & high score for symptom scale=high level of symptom severity.\nA positive change from baseline=improvement & negative change=worsening in QoL & functioning scales.\nA positive change from baseline=deterioration & negative change=improvement in symptom scales."
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/9/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/10/description",
      "value": "EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting & pain), GHS/QoL & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).\nFunctioning & symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much.\nGHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent.\nAll EORTC scales & single-item measures were linearly transformed to a score range of 0-100.\nHigh score for functional/GHS scale=high/healthy level of functioning/better HRQoL & high score for symptom scale=high level of symptom severity.\nA positive change from baseline=improvement & negative change=worsening in QoL & functioning scales.\nA positive change from baseline=deterioration & negative change=improvement in symptom scales."
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/10/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/16/description",
      "value": "HCPs who have had experience with the preparation and/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: <12 months, ≥12 months, 18 months, <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's treatment will be SC until the full 18 cycles?\nThe 3 available responses were: Yes, No, and Unsure.\nPercentages were rounded off."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/19/description",
      "value": "EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting & pain), GHS/QoL & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).\nFunctioning & symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much.\nGHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent.\nAll EORTC scales & single-item measures were linearly transformed to a score range of 0-100.\nHigh score for functional/GHS scale=high/healthy level of functioning/better HRQoL & high score for symptom scale=high level of symptom severity.\nA positive change from baseline=improvement & negative change=worsening in QoL & functioning scales.\nA positive change from baseline=deterioration & negative change=improvement in symptom scales."
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/0/facility",
      "value": "Centro de Investigaciones Médicas y Desarrollo LC S.R.L"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/0/zip",
      "value": "C1113AAE"
    },
    {
      "op": "add",
      "path": "/protocolSection/contactsLocationsModule/locations/0/state",
      "value": "Ciudad Autónoma de BuenosAires"
    },
    {
      "op": "add",
      "path": "/resultsSection/participantFlowModule/periods/0/milestones/6",
      "value": {
        "achievements": [
          {
            "groupId": "FG000",
            "numSubjects": "1"
          },
          {
            "groupId": "FG001",
            "numSubjects": "0"
          },
          {
            "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": "Switched From IV to SC Treatment"
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription",
      "value": "Participants could have changed from P+H IV treatment to PH FDC SC treatment, in exceptional circumstances and at the investigator discretion.\nOverall 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."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/measureCategoriesReviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/populationDescription",
      "value": "Participants could have changed from P+H IV treatment to PH FDC SC treatment, in exceptional circumstances and at the investigator discretion.\nOverall 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."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/measureCategoriesReviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/timeFrame",
      "value": "Up to approximately 7.8 months"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/10/description",
      "value": "EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting & pain), global health status/quality of life (GHS/QoL) & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).\nFunctioning & symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much.\nGHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent.\nAll EORTC scales & single-item measures were linearly transformed to a score range of 0-100.\nHigh score for functional/GHS scale=high/healthy level of functioning/better HRQoL & high score for symptom scale=high level of symptom severity.\nA positive change from baseline=improvement & negative change=worsening in QoL & functioning scales.\nA positive change from baseline=deterioration & negative change=improvement in symptom scales."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/10/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/11/description",
      "value": "EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting & pain), GHS/QoL & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).\nFunctioning & symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much.\nGHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent.\nAll EORTC scales & single-item measures were linearly transformed to a score range of 0-100.\nHigh score for functional/GHS scale=high/healthy level of functioning/better HRQoL & high score for symptom scale=high level of symptom severity.\nA positive change from baseline=improvement & negative change=worsening in QoL & functioning scales.\nA positive change from baseline=deterioration & negative change=improvement in symptom scales."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/11/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/17/description",
      "value": "HCPs who have had experience with the preparation and/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: <12 months, ≥12 months, 18 months, <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's treatment will be SC until the full 18 cycles?\nThe 3 available responses were: Yes, No, and Unsure.\nPercentages were rounded off."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/20/description",
      "value": "EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting & pain), GHS/QoL & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).\nFunctioning & symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much.\nGHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent.\nAll EORTC scales & single-item measures were linearly transformed to a score range of 0-100.\nHigh score for functional/GHS scale=high/healthy level of functioning/better HRQoL & high score for symptom scale=high level of symptom severity.\nA positive change from baseline=improvement & negative change=worsening in QoL & functioning scales.\nA positive change from baseline=deterioration & negative change=improvement in symptom scales."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/24/populationDescription",
      "value": "Adjuvant safety analysis set (SAScd+) included all participants with pCR who received at least one dose of PH FDC SC during the adjuvant phase.\nAEs for the cross-over period are pooled per treatment administration setting."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/24/groups/0/title",
      "value": "Adjuvant Cross-Over Period: PH FDC SC in Hospital"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/24/groups/0/description",
      "value": "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)."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/24/groups/1/title",
      "value": "Adjuvant Cross-Over Period: PH FDC SC at Home"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/24/groups/1/description",
      "value": "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)."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/24/measureCategoriesReviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/25/populationDescription",
      "value": "SAScd+ included all participants with pCR who received at least one dose of PH FDC SC during the adjuvant phase.\nAEs for the cross-over period are pooled per treatment administration setting."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/25/groups/0/title",
      "value": "Adjuvant Cross-Over Period: PH FDC SC in Hospital"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/25/groups/0/description",
      "value": "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)."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/25/groups/1/title",
      "value": "Adjuvant Cross-Over Period: PH FDC SC at Home"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/25/groups/1/description",
      "value": "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)."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/25/measureCategoriesReviewUnit"
    },
    {
      "op": "remove",
      "path": "/annotationSection"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "9c891769a5458f5fa7f52f57518111d2c844ed94930779e19828905283a5edb0",
    "materiality_event_hash": "d6026f2099209456a44cbf2c04251c836786d45a27e1407463595031e391f8f9",
    "patch_hash": "892b75be997beb5225cd295dd135b61bdb49ea821ae8f031e8b3a07285914fb6",
    "patch_raw_hash": "9757c87915ba84a59e7a021ee5c40d98944cedca0cd009007832631b56a939f1",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT05415215/history/30?patchToVersion=31",
    "to_snapshot_hash": "4f228efc62e20b638c1c649c9462e2acf0c8a76e87358cc9b64b8ffb13775dad"
  },
  "review_question": "What source document explains this registry amendment, and does it change interpretation of the trial record?",
  "schema": "trialdiff.evidence_record",
  "trial": {
    "clinicaltrials_gov_url": "https://clinicaltrials.gov/study/NCT05415215",
    "nct_id": "NCT05415215"
  },
  "versions": {
    "from_version": 30,
    "submitted_date": "2025-12-18",
    "to_version": 31
  }
}