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Evidence Record

evt_NCT03734029_v27_v28_660d8b09feb1

NCT03734029 · Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

View field-level diff Canonical JSON Supersession index ClinicalTrials.gov
Severity is deterministic, reproducible, uncalibrated triage metadata, not validated review priority or proven wrongdoing. This page states what the registry evidence supports and what it does not support.
Triage severity
Triage: High
Category
Eligibility Change
Versions
v27 to v28
Timing
Late Recruitment

Claims Supported

  • TrialDiff compared ClinicalTrials.gov record version 27 to version 28 for NCT03734029.
  • The JSON Patch for this comparison has hash 41ca196b320b157d901f92c081c34d92d46b4dfdb428ad32ef06472cbfa780bf.
  • The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.
  • The deterministic triage label was high; before timing adjustment it was high.
  • 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.
  • A registry field under the eligibility module changed between ClinicalTrials.gov versions 27 and 28.
  • The timing context for the from-version record was late_recruitment.
  • The deterministic rules that fired were: eligibility_criteria_change.
  • The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4, /protocolSection/outcomesModule/secondaryOutcomes/5, /protocolSection/outcomesModule/secondaryOutcomes/6, /protocolSection/outcomesModule/secondaryOutcomes/7, /protocolSection/outcomesModule/secondaryOutcomes/8, /protocolSection/eligibilityModule/eligibilityCriteria, /protocolSection/referencesModule/references/0, /protocolSection/referencesModule/references/8, /protocolSection/ipdSharingStatementModule/infoTypes/2, /hasResults, /resultsSection, /annotationSection, /documentSection.
  • An outcome path changed between versions 27 and 28 in a patch that also carried a hasResults or resultsSection co-occurrence signal.

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.

Neutral Review Question

What source document explains this registry amendment, and does it change interpretation of the trial record?

Citation

TrialDiff Evidence Record evt_NCT03734029_v27_v28_660d8b09feb1. ClinicalTrials.gov NCT03734029, versions 27-28. Evidence version 1.

Event Classes

outcome_edit_cooccurs_with_results_posting

Changed Paths

/protocolSection/statusModule/statusVerifiedDate
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/outcomesModule/primaryOutcomes/0/measure
/protocolSection/outcomesModule/primaryOutcomes/0/description
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/0/measure
/protocolSection/outcomesModule/secondaryOutcomes/0/description
/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/1/measure
/protocolSection/outcomesModule/secondaryOutcomes/1/description
/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/2/measure
/protocolSection/outcomesModule/secondaryOutcomes/2/description
/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/3/measure
/protocolSection/outcomesModule/secondaryOutcomes/3/description
/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/4
/protocolSection/outcomesModule/secondaryOutcomes/5
/protocolSection/outcomesModule/secondaryOutcomes/6
/protocolSection/outcomesModule/secondaryOutcomes/7
/protocolSection/outcomesModule/secondaryOutcomes/8
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/referencesModule/references/0
/protocolSection/referencesModule/references/8
/protocolSection/ipdSharingStatementModule/infoTypes/2
/hasResults
/resultsSection
/annotationSection
/documentSection

View the field-level diff for before/after values on each changed path.

Deterministic Rules

eligibility_criteria_change

Provenance

Package generation
v0.1.3 (active)
Supersedes
evt_NCT03734029_v27_v28_f804c62fc3af
Patch hash
41ca196b320b157d901f92c081c34d92d46b4dfdb428ad32ef06472cbfa780bf
Canonical hash
ca3f9c454374edd1a47b301bf4e6df9964d0a956d5799f47dbba72d7062d6055
Rule set hash
fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621
From snapshot
1f9dc53eb5d68175ab0d4c061209772d12c6b0dd3fc15af312c9e6d6251a2069
To snapshot
be9bef7da47603ccba272d37a7261abda3a43507b62316e0458a7f730a53e180
Patch source
ctgov_internal_history
Generated at
2026-08-03T06:46:43.000Z
Source URL
Registry payload

Canonical JSON Preview

Stored payload 
{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/resultsFirstSubmitDate",
    "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/4",
    "/protocolSection/outcomesModule/secondaryOutcomes/5",
    "/protocolSection/outcomesModule/secondaryOutcomes/6",
    "/protocolSection/outcomesModule/secondaryOutcomes/7",
    "/protocolSection/outcomesModule/secondaryOutcomes/8",
    "/protocolSection/eligibilityModule/eligibilityCriteria",
    "/protocolSection/referencesModule/references/0",
    "/protocolSection/referencesModule/references/8",
    "/protocolSection/ipdSharingStatementModule/infoTypes/2",
    "/hasResults",
    "/resultsSection",
    "/annotationSection",
    "/documentSection"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT03734029_v27_v28_660d8b09feb1. ClinicalTrials.gov NCT03734029, versions 27-28. 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 27 to version 28 for NCT03734029.",
    "The JSON Patch for this comparison has hash 41ca196b320b157d901f92c081c34d92d46b4dfdb428ad32ef06472cbfa780bf.",
    "The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
    "The deterministic triage label was high; before timing adjustment it was high.",
    "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.",
    "A registry field under the eligibility module changed between ClinicalTrials.gov versions 27 and 28.",
    "The timing context for the from-version record was late_recruitment.",
    "The deterministic rules that fired were: eligibility_criteria_change.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4, /protocolSection/outcomesModule/secondaryOutcomes/5, /protocolSection/outcomesModule/secondaryOutcomes/6, /protocolSection/outcomesModule/secondaryOutcomes/7, /protocolSection/outcomesModule/secondaryOutcomes/8, /protocolSection/eligibilityModule/eligibilityCriteria, /protocolSection/referencesModule/references/0, /protocolSection/referencesModule/references/8, /protocolSection/ipdSharingStatementModule/infoTypes/2, /hasResults, /resultsSection, /annotationSection, /documentSection.",
    "An outcome path changed between versions 27 and 28 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "eligibility_change",
      "results_reconciliation"
    ],
    "category": "eligibility_change",
    "deterministic_rules": [
      "eligibility_criteria_change"
    ],
    "event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting"
    ],
    "rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
    "severity": "high",
    "severity_pre_timing": "high",
    "timing_context": "late_recruitment",
    "triage_label": "high",
    "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/2/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/4",
          "/protocolSection/outcomesModule/secondaryOutcomes/5",
          "/protocolSection/outcomesModule/secondaryOutcomes/6",
          "/protocolSection/outcomesModule/secondaryOutcomes/7",
          "/protocolSection/outcomesModule/secondaryOutcomes/8"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT03734029_v27_v28_660d8b09feb1",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2023-01"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2023-01-11"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2023-02-10"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitDate",
      "value": "2023-01-11"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "value": "Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "value": "Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.\nPFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.\nMedian PFS was from Kaplan-Meier analysis.\nConfidence interval for median was computed using the Brookmeyer-Crowley method."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "value": "From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
      "value": "Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-low Breast Cancer (All Patients) Regardless of Hormone Receptor Status"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
      "value": "Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.\nPFS was based on blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.\nMedian PFS was from Kaplan-Meier analysis.\nConfidence interval for median was computed using the Brookmeyer-Crowley method."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
      "value": "From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
      "value": "Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
      "value": "Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.\nIf there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
      "value": "From the date of randomization up to the date of death due to any cause, up to approximately 3 years"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
      "value": "Overall Survival (OS) in Participants With HER2-low Breast Cancer (All Patients)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
      "value": "Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.\nIf there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
      "value": "From the date of randomization up to the date of death due to any cause, up to approximately 3 years"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
      "value": "Progression-free Survival Based on Investigator Assessment in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
      "value": "Progression-free survival (PFS) was defined as the time from the date of randomization to the first objective documentation of radiographic disease progression or death due to any cause, whichever came first.\nPFS was based on investigator assessment in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.\nMedian PFS was from Kaplan-Meier analysis.\nConfidence interval for median was computed using the Brookmeyer-Crowley method."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
      "value": "From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4",
      "value": {
        "description": "Progression-free survival (PFS) was defined as the time from the date of randomization to the first objective documentation of radiographic disease progression or death due to any cause, whichever came first.\nPFS was based on investigator assessment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.\nMedian PFS was from Kaplan-Meier analysis.\nConfidence interval for median was computed using the Brookmeyer-Crowley method.",
        "measure": "Progression-free Survival Based on Investigator Assessment in Participants With HER2-low Breast Cancer (All Patients)",
        "timeFrame": "From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5",
      "value": {
        "description": "Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment.\nComplete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.\nORR is defined as the number of participants with complete and partial responses.",
        "measure": "Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer",
        "timeFrame": "From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/6",
      "value": {
        "description": "Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment.\nComplete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.\nORR is defined as the number of participants with complete and partial responses.",
        "measure": "Best Overall Response and Confirmed Objective Response Rate (ORR) in Participants With HER2-low Breast Cancer (All Patients)",
        "timeFrame": "From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/7",
      "value": {
        "description": "Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first.\nDoR was based on blinded independent central review (BICR) and investigator assessment.\nMedian was from Kaplan-Meier estimate.\nConfidence interval for median was computed using the Brookmeyer-Crowley method.",
        "measure": "Duration of Response in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer",
        "timeFrame": "From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/8",
      "value": {
        "description": "Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first.\nDoR was based on blinded independent central review (BICR) and investigator assessment.\nMedian was from Kaplan-Meier estimate.\nConfidence interval for median was computed using the Brookmeyer-Crowley method.",
        "measure": "Duration of Response in Participants With HER2-low Breast Cancer (All Patients)",
        "timeFrame": "From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
      "value": "<p>Inclusion Criteria:</p><ul><li>Is the age of majority in their country</li><li><p>Has pathologically documented breast cancer that:</p><ol><li>Is unresectable or metastatic</li><li>Has low-HER2 expression defined as IHC 2+&#x2F;ISH- or IHC 1+ (ISH- or untested)</li><li>Is HR-positive or HR-negative</li><li>Has progressed on, and would no longer benefit from, endocrine therapy</li><li>Has been treated with 1 to 2 prior lines of chemotherapy&#x2F;adjuvant in the recurrent or metastatic setting</li><li>Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines)</li></ol></li><li>Has documented radiologic progression (during or after most recent treatment)</li><li><p>Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for:</p><ol><li>assessment of HER2 status</li><li>assessment of post-treatment status</li></ol></li><li>Has at least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors 1.1</li><li>Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions</li><li>Male and female participants of reproductive&#x2F;childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)</li></ul><p>Exclusion Criteria:</p><ul><li>Is ineligible for all options in the physician&#x27;s choice arm</li><li>Has breast cancer ever assessed with high-HER2 expression</li><li>Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate</li><li>Has uncontrolled or significant cardiovascular disease</li><li>Has spinal cord compression or clinically active central nervous system metastases</li><li>Has history of (noninfectious) interstitial lung disease (ILD)&#x2F;pneumonitis that required steroids, has current ILD&#x2F;pneumonitis, or suspected ILD&#x2F;pneumonitis that cannot be ruled out by imaging at screening</li><li>Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study</li></ul>"
    },
    {
      "op": "add",
      "path": "/protocolSection/referencesModule/references/0",
      "value": {
        "citation": "Modi S, Jacot W, Yamashita T, Sohn J, Vidal M, Tokunaga E, Tsurutani J, Ueno NT, Prat A, Chae YS, Lee KS, Niikura N, Park YH, Xu B, Wang X, Gil-Gil M, Li W, Pierga JY, Im SA, Moore HCF, Rugo HS, Yerushalmi R, Zagouri F, Gombos A, Kim SB, Liu Q, Luo T, Saura C, Schmid P, Sun T, Gambhire D, Yung L, Wang Y, Singh J, Vitazka P, Meinhardt G, Harbeck N, Cameron DA; DESTINY-Breast04 Trial Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. N Engl J Med. 2022 Jul 7;387(1):9-20. doi: 10.1056&#x2F;NEJMoa2203690. Epub 2022 Jun 5.",
        "pmid": "35665782",
        "type": "RESULT"
      }
    },
    {
      "op": "remove",
      "path": "/protocolSection/referencesModule/references/8"
    },
    {
      "op": "replace",
      "path": "/protocolSection/ipdSharingStatementModule/infoTypes/2",
      "value": "ICF"
    },
    {
      "op": "replace",
      "path": "/hasResults",
      "value": true
    },
    {
      "op": "add",
      "path": "/resultsSection",
      "value": {
        "adverseEventsModule": {
          "allCauseMortalityReviewUnit": {
            "resetReasons": [
              "The number of participants at risk appears inconsistent with data here or in other parts of the record."
            ]
          },
          "armsReviewUnit": {
            "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."
            ]
          },
          "description": "The Safety Analysis Set included all randomized participants who received at least 1 dose of treatment.\nAn adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with that product.\nA TEAE was an AE that occurred, having been absent before the first dose of study drug, or worsened in severity or seriousness after initiating study drug up to 47 days after the last dose of the study drug.",
          "eventGroups": [
            {
              "deathsNumAffected": 148,
              "deathsNumAtRisk": 371,
              "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg&#x2F;kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg&#x2F;kg were infused for a minimum of 30 minutes.",
              "id": "EG000",
              "otherNumAffected": 369,
              "otherNumAtRisk": 371,
              "seriousNumAffected": 103,
              "seriousNumAtRisk": 371,
              "title": "Trastuzumab Deruxtecan (T-DXd)"
            },
            {
              "deathsNumAffected": 88,
              "deathsNumAtRisk": 172,
              "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician&#x27;s choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.",
              "id": "EG001",
              "otherNumAffected": 169,
              "otherNumAtRisk": 172,
              "seriousNumAffected": 43,
              "seriousNumAtRisk": 172,
              "title": "Physician&#x27;s Choice"
            }
          ],
          "frequencyThreshold": "5",
          "otherEvents": [
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Blood and lymphatic system disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 139,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 45,
                  "numAtRisk": 172
                }
              ],
              "term": "Anaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Blood and lymphatic system disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 49,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 31,
                  "numAtRisk": 172
                }
              ],
              "term": "Neutropenia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Blood and lymphatic system disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 23,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 4,
                  "numAtRisk": 172
                }
              ],
              "term": "Thrombocytopenia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 282,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 52,
                  "numAtRisk": 172
                }
              ],
              "term": "Nausea"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 150,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 23,
                  "numAtRisk": 172
                }
              ],
              "term": "Vomiting"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 126,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 38,
                  "numAtRisk": 172
                }
              ],
              "term": "Constipation"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 100,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 38,
                  "numAtRisk": 172
                }
              ],
              "term": "Diarrhoea"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 41,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 17,
                  "numAtRisk": 172
                }
              ],
              "term": "Stomatitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 35,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 8,
                  "numAtRisk": 172
                }
              ],
              "term": "Abdominal pain"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 34,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 11,
                  "numAtRisk": 172
                }
              ],
              "term": "Dyspepsia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 31,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 13,
                  "numAtRisk": 172
                }
              ],
              "term": "Abdominal pain upper"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 26,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 9,
                  "numAtRisk": 172
                }
              ],
              "term": "Dry mouth"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 23,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 3,
                  "numAtRisk": 172
                }
              ],
              "term": "Gastrooesophageal reflux disease"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 20,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 5,
                  "numAtRisk": 172
                }
              ],
              "term": "Abdominal distension"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 110,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 50,
                  "numAtRisk": 172
                }
              ],
              "term": "Fatigue"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 70,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 25,
                  "numAtRisk": 172
                }
              ],
              "term": "Asthenia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 46,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 22,
                  "numAtRisk": 172
                }
              ],
              "term": "Pyrexia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 33,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 11,
                  "numAtRisk": 172
                }
              ],
              "term": "Malaise"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 25,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 10,
                  "numAtRisk": 172
                }
              ],
              "term": "Oedema peripheral"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 29,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 6,
                  "numAtRisk": 172
                }
              ],
              "term": "Urinary tract infection"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 11,
                  "numAtRisk": 172
                }
              ],
              "term": "Medication error"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 92,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 42,
                  "numAtRisk": 172
                }
              ],
              "term": "Aspartate aminotransferase increased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 81,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 62,
                  "numAtRisk": 172
                }
              ],
              "term": "Neutrophil count decreased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 78,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 49,
                  "numAtRisk": 172
                }
              ],
              "term": "White blood cell count decreased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 75,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 43,
                  "numAtRisk": 172
                }
              ],
              "term": "Alanine aminotransferase increased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 73,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 12,
                  "numAtRisk": 172
                }
              ],
              "term": "Platelet count decreased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 60,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 14,
                  "numAtRisk": 172
                }
              ],
              "term": "Weight decreased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 36,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 5,
                  "numAtRisk": 172
                }
              ],
              "term": "Blood alkaline phosphatase increased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 29,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 12,
                  "numAtRisk": 172
                }
              ],
              "term": "Lymphocyte count decreased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 26,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 7,
                  "numAtRisk": 172
                }
              ],
              "term": "Blood bilirubin increased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 20,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 8,
                  "numAtRisk": 172
                }
              ],
              "term": "Gamma-glutamyltransferase increased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 19,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 9,
                  "numAtRisk": 172
                }
              ],
              "term": "Blood lactate dehydrogenase increased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 118,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 33,
                  "numAtRisk": 172
                }
              ],
              "term": "Decreased appetite"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 39,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 12,
                  "numAtRisk": 172
                }
              ],
              "term": "Hypokalaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 32,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 8,
                  "numAtRisk": 172
                }
              ],
              "term": "Hypoalbuminaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 19,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 5,
                  "numAtRisk": 172
                }
              ],
              "term": "Hypocalcaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 43,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 20,
                  "numAtRisk": 172
                }
              ],
              "term": "Arthralgia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 34,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 10,
                  "numAtRisk": 172
                }
              ],
              "term": "Back pain"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 29,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 5,
                  "numAtRisk": 172
                }
              ],
              "term": "Pain in extremity"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 22,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 16,
                  "numAtRisk": 172
                }
              ],
              "term": "Myalgia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 54,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 11,
                  "numAtRisk": 172
                }
              ],
              "term": "Headache"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 37,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 16,
                  "numAtRisk": 172
                }
              ],
              "term": "Dysgeusia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 32,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 9,
                  "numAtRisk": 172
                }
              ],
              "term": "Dizziness"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 18,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 19,
                  "numAtRisk": 172
                }
              ],
              "term": "Peripheral sensory neuropathy"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 13,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 16,
                  "numAtRisk": 172
                }
              ],
              "term": "Neuropathy peripheral"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 8,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 9,
                  "numAtRisk": 172
                }
              ],
              "term": "Paraesthesia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Psychiatric disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 24,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 9,
                  "numAtRisk": 172
                }
              ],
              "term": "Insomnia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 39,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 2,
                  "numAtRisk": 172
                }
              ],
              "term": "Epistaxis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 38,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 16,
                  "numAtRisk": 172
                }
              ],
              "term": "Dyspnoea"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
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                {
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              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
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                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Urosepsis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
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                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Appendicitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Cellulitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
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                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Cytomegalovirus infection reactivation"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Device related infection"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Empyema"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Escherichia bacteraemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Herpes zoster"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Osteomyelitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Peritonitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Peritonitis bacterial"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Pneumocystis jirovecii pneumonia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Pyelonephritis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Staphylococcal bacteraemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Streptococcal bacteraemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Upper respiratory tract infection"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 172
                }
              ],
              "term": "Thoracic vertebral fracture"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Ankle fracture"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Chemical peritonitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Fall"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Femoral neck fracture"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Radius fracture"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Tracheal obstruction"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 5,
                  "numAtRisk": 172
                }
              ],
              "term": "Overdose"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 3,
                  "numAtRisk": 172
                }
              ],
              "term": "Medication error"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 2,
                  "numAtRisk": 172
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              ],
              "term": "Femur fracture"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 172
                }
              ],
              "term": "Accidental overdose"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 172
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              ],
              "term": "Lumbar vertebral fracture"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 2,
                  "numAtRisk": 172
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              ],
              "term": "Neutrophil count decreased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Platelet count decreased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Blood bilirubin increased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Blood creatinine increased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Weight decreased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 4,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Hypercalcaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 2,
                  "numAtRisk": 172
                }
              ],
              "term": "Hyponatraemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Cachexia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Hypokalaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Hypomagnesaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Bone pain"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 172
                }
              ],
              "term": "Osteonecrosis of jaw"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Back pain"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Intervertebral disc protrusion"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
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                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Musculoskeletal chest pain"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Pain in extremity"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Pathological fracture"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 172
                }
              ],
              "term": "Muscular weakness"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Meningioma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 172
                }
              ],
              "term": "Adenocarcinoma gastric"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 172
                }
              ],
              "term": "Metastases to meninges"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
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              ],
              "term": "Epilepsy"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Headache"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Movement disorder"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 172
                }
              ],
              "term": "Hypoglycaemic coma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Psychiatric disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 172
                }
              ],
              "term": "Confusional state"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Renal and urinary disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Hydronephrosis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Renal and urinary disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Renal colic"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Renal and urinary disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Renal failure"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Renal and urinary disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 172
                }
              ],
              "term": "Ureteric obstruction"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 7,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Interstitial lung disease"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 7,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Pneumonitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 5,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 2,
                  "numAtRisk": 172
                }
              ],
              "term": "Dyspnoea"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 3,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 2,
                  "numAtRisk": 172
                }
              ],
              "term": "Pleural effusion"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Cough"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Haemoptysis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Hydrothorax"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Pulmonary embolism"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Pulmonary toxicity"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Respiratory failure"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 172
                }
              ],
              "term": "Hypoxia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Social circumstances",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Social problem"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 172
                }
              ],
              "term": "Embolism"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 172
                }
              ],
              "term": "Hypotension"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA 24.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 371
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 172
                }
              ],
              "term": "Superior vena cava occlusion"
            }
          ],
          "timeFrame": "Treatment-emergent adverse events (TEAEs) were collected from the time of signing the main informed consent form up to 40 days (+7 days) after the last treatment, whether observed by the investigator or reported by the participant, up to approximately 3 years in the Safety Analysis Set."
        },
        "baselineCharacteristicsModule": {
          "denoms": [
            {
              "counts": [
                {
                  "groupId": "BG000",
                  "value": "373"
                },
                {
                  "groupId": "BG001",
                  "value": "184"
                },
                {
                  "groupId": "BG002",
                  "value": "557"
                }
              ],
              "units": "Participants"
            }
          ],
          "groups": [
            {
              "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg&#x2F;kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg&#x2F;kg were infused for a minimum of 30 minutes.",
              "id": "BG000",
              "title": "Trastuzumab Deruxtecan (T-DXd)"
            },
            {
              "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician&#x27;s choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.",
              "id": "BG001",
              "title": "Physician&#x27;s Choice"
            },
            {
              "description": "Total of all reporting groups",
              "id": "BG002",
              "title": "Total"
            }
          ],
          "measures": [
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        }
                      ],
                      "title": "&lt;=18 years"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "290"
                        },
                        {
                          "groupId": "BG001",
                          "value": "136"
                        },
                        {
                          "groupId": "BG002",
                          "value": "426"
                        }
                      ],
                      "title": "Between 18 and 65 years"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "83"
                        },
                        {
                          "groupId": "BG001",
                          "value": "48"
                        },
                        {
                          "groupId": "BG002",
                          "value": "131"
                        }
                      ],
                      "title": "&gt;=65 years"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Age, Categorical",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "spread": "10.6",
                          "value": "56.5"
                        },
                        {
                          "groupId": "BG001",
                          "spread": "11.5",
                          "value": "56.5"
                        },
                        {
                          "groupId": "BG002",
                          "spread": "10.9",
                          "value": "56.5"
                        }
                      ]
                    }
                  ]
                }
              ],
              "dispersionType": "STANDARD_DEVIATION",
              "paramType": "MEAN",
              "title": "Age, Continuous",
              "unitOfMeasure": "years"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "371"
                        },
                        {
                          "groupId": "BG001",
                          "value": "184"
                        },
                        {
                          "groupId": "BG002",
                          "value": "555"
                        }
                      ],
                      "title": "Female"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "2"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "2"
                        }
                      ],
                      "title": "Male"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Sex: Female, Male",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "176"
                        },
                        {
                          "groupId": "BG001",
                          "value": "91"
                        },
                        {
                          "groupId": "BG002",
                          "value": "267"
                        }
                      ]
                    }
                  ],
                  "title": "White"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "7"
                        },
                        {
                          "groupId": "BG001",
                          "value": "3"
                        },
                        {
                          "groupId": "BG002",
                          "value": "10"
                        }
                      ]
                    }
                  ],
                  "title": "Black or African American"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "151"
                        },
                        {
                          "groupId": "BG001",
                          "value": "72"
                        },
                        {
                          "groupId": "BG002",
                          "value": "223"
                        }
                      ]
                    }
                  ],
                  "title": "Asian"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "1"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "Native Hawaiian or other Pacific Islander"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "38"
                        },
                        {
                          "groupId": "BG001",
                          "value": "17"
                        },
                        {
                          "groupId": "BG002",
                          "value": "55"
                        }
                      ]
                    }
                  ],
                  "title": "Other"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "1"
                        },
                        {
                          "groupId": "BG002",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "Missing"
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Race&#x2F;Ethnicity, Customized",
              "unitOfMeasure": "Participants"
            }
          ],
          "populationDescription": "Baseline characteristics were assessed in the Full Analysis Set.\nThe Full Analysis Set included all participants randomized into the study, including those who did not receive a dose of study treatment.\nParticipants were analyzed according to the treatments and strata assigned at randomization."
        },
        "moreInfoModule": {
          "certainAgreement": {
            "piSponsorEmployee": false,
            "restrictiveAgreement": false
          },
          "pointOfContact": {
            "email": "CTRinfo@dsi.com",
            "organization": "Daiichi Sankyo",
            "phone": "908-992-6400",
            "title": "Contact for Clinical Trial Information"
          }
        },
        "outcomeMeasuresModule": {
          "outcomeMeasures": [
            {
              "analyses": [
                {
                  "ciLowerLimit": "0.4012",
                  "ciNumSides": "TWO_SIDED",
                  "ciPctValue": "95",
                  "ciUpperLimit": "0.6444",
                  "groupIds": [
                    "OG000",
                    "OG001"
                  ],
                  "nonInferiorityType": "SUPERIORITY",
                  "pValue": "&lt;0.0001",
                  "pValueComment": "Two-sided p-value from stratified log-rank test, Hazard ratio and 95% CI from stratified Cox proportional hazards model using stratification factors: HER2 status, number of prior lines of chemotherapy, hormone Receptor&#x2F;CDK status, as defined by IXRS.",
                  "paramType": "Cox Proportional Hazard",
                  "paramValue": "0.5085",
                  "statisticalMethod": "Log Rank"
                }
              ],
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "9.5",
                          "upperLimit": "11.5",
                          "value": "10.1"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "4.4",
                          "upperLimit": "7.1",
                          "value": "5.4"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "331"
                    },
                    {
                      "groupId": "OG001",
                      "value": "163"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.\nPFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.\nMedian PFS was from Kaplan-Meier analysis.\nConfidence interval for median was computed using the Brookmeyer-Crowley method.",
              "dispersionType": "95% Confidence Interval",
              "groups": [
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg&#x2F;kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg&#x2F;kg were infused for a minimum of 30 minutes.",
                  "id": "OG000",
                  "title": "Trastuzumab Deruxtecan (T-DXd)"
                },
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician&#x27;s choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.",
                  "id": "OG001",
                  "title": "Physician&#x27;s Choice"
                }
              ],
              "paramType": "MEDIAN",
              "populationDescription": "Progression-free survival (PFS) was assessed in the Hormone Receptor-Positive cohort of Full Analysis Set.",
              "reportingStatus": "POSTED",
              "timeFrame": "From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years",
              "title": "Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer",
              "type": "PRIMARY",
              "unitOfMeasure": "months"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "9.0",
                          "upperLimit": "11.3",
                          "value": "9.9"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "4.2",
                          "upperLimit": "6.8",
                          "value": "5.1"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "373"
                    },
                    {
                      "groupId": "OG001",
                      "value": "184"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.\nPFS was based on blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.\nMedian PFS was from Kaplan-Meier analysis.\nConfidence interval for median was computed using the Brookmeyer-Crowley method.",
              "dispersionType": "95% Confidence Interval",
              "groups": [
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg&#x2F;kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg&#x2F;kg were infused for a minimum of 30 minutes.",
                  "id": "OG000",
                  "title": "Trastuzumab Deruxtecan (T-DXd)"
                },
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician&#x27;s choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.",
                  "id": "OG001",
                  "title": "Physician&#x27;s Choice"
                }
              ],
              "paramType": "MEDIAN",
              "populationDescription": "Progression-free survival (PFS) was assessed in the Full Analysis Set.",
              "reportingStatus": "POSTED",
              "timeFrame": "From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years",
              "title": "Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-low Breast Cancer (All Patients) Regardless of Hormone Receptor Status",
              "type": "SECONDARY",
              "unitOfMeasure": "months"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "20.8",
                          "upperLimit": "24.8",
                          "value": "23.9"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "15.2",
                          "upperLimit": "22.4",
                          "value": "17.5"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "331"
                    },
                    {
                      "groupId": "OG001",
                      "value": "163"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.\nIf there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive.",
              "dispersionType": "95% Confidence Interval",
              "groups": [
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg&#x2F;kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg&#x2F;kg were infused for a minimum of 30 minutes.",
                  "id": "OG000",
                  "title": "Trastuzumab Deruxtecan (T-DXd)"
                },
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician&#x27;s choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.",
                  "id": "OG001",
                  "title": "Physician&#x27;s Choice"
                }
              ],
              "paramType": "MEDIAN",
              "populationDescription": "Overall survival (OS) was assessed in the Hormone Receptor-Positive cohort of Full Analysis Set.",
              "reportingStatus": "POSTED",
              "timeFrame": "From the date of randomization up to the date of death due to any cause, up to approximately 3 years",
              "title": "Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer",
              "type": "SECONDARY",
              "unitOfMeasure": "months"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "20.0",
                          "upperLimit": "24.8",
                          "value": "23.4"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "14.5",
                          "upperLimit": "20.0",
                          "value": "16.8"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "373"
                    },
                    {
                      "groupId": "OG001",
                      "value": "184"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.\nIf there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive.",
              "dispersionType": "95% Confidence Interval",
              "groups": [
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg&#x2F;kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg&#x2F;kg were infused for a minimum of 30 minutes.",
                  "id": "OG000",
                  "title": "Trastuzumab Deruxtecan (T-DXd)"
                },
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician&#x27;s choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.",
                  "id": "OG001",
                  "title": "Physician&#x27;s Choice"
                }
              ],
              "paramType": "MEDIAN",
              "populationDescription": "Overall survival (OS) was assessed in the Full Analysis Set.",
              "reportingStatus": "POSTED",
              "timeFrame": "From the date of randomization up to the date of death due to any cause, up to approximately 3 years",
              "title": "Overall Survival (OS) in Participants With HER2-low Breast Cancer (All Patients)",
              "type": "SECONDARY",
              "unitOfMeasure": "months"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "8.4",
                          "upperLimit": "10.0",
                          "value": "9.6"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "3.4",
                          "upperLimit": "4.9",
                          "value": "4.2"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "331"
                    },
                    {
                      "groupId": "OG001",
                      "value": "163"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Progression-free survival (PFS) was defined as the time from the date of randomization to the first objective documentation of radiographic disease progression or death due to any cause, whichever came first.\nPFS was based on investigator assessment in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.\nMedian PFS was from Kaplan-Meier analysis.\nConfidence interval for median was computed using the Brookmeyer-Crowley method.",
              "dispersionType": "95% Confidence Interval",
              "groups": [
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg&#x2F;kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg&#x2F;kg were infused for a minimum of 30 minutes.",
                  "id": "OG000",
                  "title": "Trastuzumab Deruxtecan (T-DXd)"
                },
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician&#x27;s choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.",
                  "id": "OG001",
                  "title": "Physician&#x27;s Choice"
                }
              ],
              "measureCategoriesReviewUnit": {
                "resetReasons": [
                  "The Measure Type appears inaccurate."
                ]
              },
              "paramType": "NUMBER",
              "populationDescription": "Progression-free survival (PFS) was assessed in the Hormone Receptor-Positive cohort of Full Analysis Set.",
              "reportingStatus": "POSTED",
              "timeFrame": "From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years",
              "title": "Progression-free Survival Based on Investigator Assessment in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer",
              "type": "SECONDARY",
              "unitOfMeasure": "months"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "8.3",
                          "upperLimit": "9.8",
                          "value": "8.8"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "3.0",
                          "upperLimit": "4.5",
                          "value": "4.2"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "373"
                    },
                    {
                      "groupId": "OG001",
                      "value": "184"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Progression-free survival (PFS) was defined as the time from the date of randomization to the first objective documentation of radiographic disease progression or death due to any cause, whichever came first.\nPFS was based on investigator assessment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.\nMedian PFS was from Kaplan-Meier analysis.\nConfidence interval for median was computed using the Brookmeyer-Crowley method.",
              "dispersionType": "95% Confidence Interval",
              "groups": [
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg&#x2F;kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg&#x2F;kg were infused for a minimum of 30 minutes.",
                  "id": "OG000",
                  "title": "Trastuzumab Deruxtecan (T-DXd)"
                },
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician&#x27;s choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.",
                  "id": "OG001",
                  "title": "Physician&#x27;s Choice"
                }
              ],
              "measureCategoriesReviewUnit": {
                "resetReasons": [
                  "The Measure Type appears inaccurate."
                ]
              },
              "paramType": "NUMBER",
              "populationDescription": "Progression-free survival (PFS) was assessed in the Full Analysis Set.",
              "reportingStatus": "POSTED",
              "timeFrame": "From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years",
              "title": "Progression-free Survival Based on Investigator Assessment in Participants With HER2-low Breast Cancer (All Patients)",
              "type": "SECONDARY",
              "unitOfMeasure": "months"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "12"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "BICR: Complete response"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "164"
                        },
                        {
                          "groupId": "OG001",
                          "value": "26"
                        }
                      ]
                    }
                  ],
                  "title": "BICR: Partial response"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "115"
                        },
                        {
                          "groupId": "OG001",
                          "value": "81"
                        }
                      ]
                    }
                  ],
                  "title": "BICR: Stable disease"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "26"
                        },
                        {
                          "groupId": "OG001",
                          "value": "34"
                        }
                      ]
                    }
                  ],
                  "title": "BICR: Progressive disease"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "14"
                        },
                        {
                          "groupId": "OG001",
                          "value": "21"
                        }
                      ]
                    }
                  ],
                  "title": "BICR: Not evaluable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "title": "Investigator: Complete response"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "163"
                        },
                        {
                          "groupId": "OG001",
                          "value": "30"
                        }
                      ]
                    }
                  ],
                  "title": "Investigator: Partial response"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "124"
                        },
                        {
                          "groupId": "OG001",
                          "value": "80"
                        }
                      ]
                    }
                  ],
                  "title": "Investigator: Stable disease"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "28"
                        },
                        {
                          "groupId": "OG001",
                          "value": "34"
                        }
                      ]
                    }
                  ],
                  "title": "Investigator: Progressive disease"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "11"
                        },
                        {
                          "groupId": "OG001",
                          "value": "19"
                        }
                      ]
                    }
                  ],
                  "title": "Investigator: Not evaluable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "175"
                        },
                        {
                          "groupId": "OG001",
                          "value": "27"
                        }
                      ]
                    }
                  ],
                  "title": "BICR: Objective response rate"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "168"
                        },
                        {
                          "groupId": "OG001",
                          "value": "30"
                        }
                      ]
                    }
                  ],
                  "title": "Investigator: Objective response rate"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "331"
                    },
                    {
                      "groupId": "OG001",
                      "value": "163"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment.\nComplete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.\nORR is defined as the number of participants with complete and partial responses.",
              "groups": [
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg&#x2F;kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg&#x2F;kg were infused for a minimum of 30 minutes.",
                  "id": "OG000",
                  "title": "Trastuzumab Deruxtecan (T-DXd)"
                },
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician&#x27;s choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.",
                  "id": "OG001",
                  "title": "Physician&#x27;s Choice"
                }
              ],
              "measureCategoriesReviewUnit": {
                "resetReasons": [
                  "Information within the measure appears inconsistent."
                ]
              },
              "paramType": "COUNT_OF_PARTICIPANTS",
              "populationDescription": "Best overall response and confirmed objective response rate were assessed in the Hormone Receptor-Positive cohort of Full Analysis Set.",
              "reportingStatus": "POSTED",
              "timeFrame": "From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years",
              "title": "Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer",
              "type": "SECONDARY",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "13"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2"
                        }
                      ]
                    }
                  ],
                  "title": "BICR: Complete response"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "183"
                        },
                        {
                          "groupId": "OG001",
                          "value": "28"
                        }
                      ]
                    }
                  ],
                  "title": "BICR: Partial response"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "129"
                        },
                        {
                          "groupId": "OG001",
                          "value": "91"
                        }
                      ]
                    }
                  ],
                  "title": "BICR: Stable disease"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "31"
                        },
                        {
                          "groupId": "OG001",
                          "value": "41"
                        }
                      ]
                    }
                  ],
                  "title": "BICR: Progressive disease"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "17"
                        },
                        {
                          "groupId": "OG001",
                          "value": "22"
                        }
                      ]
                    }
                  ],
                  "title": "BICR: Not evaluable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "0"
                        }
                      ]
                    }
                  ],
                  "title": "Investigator: Complete response"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "187"
                        },
                        {
                          "groupId": "OG001",
                          "value": "31"
                        }
                      ]
                    }
                  ],
                  "title": "Investigator: Partial response"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "135"
                        },
                        {
                          "groupId": "OG001",
                          "value": "93"
                        }
                      ]
                    }
                  ],
                  "title": "Investigator: Stable disease"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "32"
                        },
                        {
                          "groupId": "OG001",
                          "value": "40"
                        }
                      ]
                    }
                  ],
                  "title": "Investigator: Progressive disease"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "13"
                        },
                        {
                          "groupId": "OG001",
                          "value": "20"
                        }
                      ]
                    }
                  ],
                  "title": "Investigator: Not evaluable"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "195"
                        },
                        {
                          "groupId": "OG001",
                          "value": "30"
                        }
                      ]
                    }
                  ],
                  "title": "BICR: Objective response rate"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "193"
                        },
                        {
                          "groupId": "OG001",
                          "value": "31"
                        }
                      ]
                    }
                  ],
                  "title": "Investigator: Objective response rate"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "373"
                    },
                    {
                      "groupId": "OG001",
                      "value": "184"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment.\nComplete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.\nORR is defined as the number of participants with complete and partial responses.",
              "groups": [
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg&#x2F;kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg&#x2F;kg were infused for a minimum of 30 minutes.",
                  "id": "OG000",
                  "title": "Trastuzumab Deruxtecan (T-DXd)"
                },
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician&#x27;s choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.",
                  "id": "OG001",
                  "title": "Physician&#x27;s Choice"
                }
              ],
              "measureCategoriesReviewUnit": {
                "resetReasons": [
                  "Information within the measure appears inconsistent."
                ]
              },
              "paramType": "COUNT_OF_PARTICIPANTS",
              "populationDescription": "Best overall response and confirmed objective response rate were assessed in the Full Analysis Set.",
              "reportingStatus": "POSTED",
              "timeFrame": "From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years",
              "title": "Best Overall Response and Confirmed Objective Response Rate (ORR) in Participants With HER2-low Breast Cancer (All Patients)",
              "type": "SECONDARY",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "8.5",
                          "upperLimit": "13.7",
                          "value": "10.7"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "6.5",
                          "upperLimit": "9.9",
                          "value": "6.8"
                        }
                      ]
                    }
                  ],
                  "title": "BICR: DoR"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "7.1",
                          "upperLimit": "11.1",
                          "value": "8.3"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "3.6",
                          "upperLimit": "6.8",
                          "value": "5.6"
                        }
                      ]
                    }
                  ],
                  "title": "Investigator: DoR"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "331"
                    },
                    {
                      "groupId": "OG001",
                      "value": "163"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first.\nDoR was based on blinded independent central review (BICR) and investigator assessment.\nMedian was from Kaplan-Meier estimate.\nConfidence interval for median was computed using the Brookmeyer-Crowley method.",
              "dispersionType": "95% Confidence Interval",
              "groups": [
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg&#x2F;kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg&#x2F;kg were infused for a minimum of 30 minutes.",
                  "id": "OG000",
                  "title": "Trastuzumab Deruxtecan (T-DXd)"
                },
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician&#x27;s choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.",
                  "id": "OG001",
                  "title": "Physician&#x27;s Choice"
                }
              ],
              "paramType": "MEDIAN",
              "populationDescription": "Duration of response was assessed in the Hormone Receptor-Positive cohort of Full Analysis Set.",
              "reportingStatus": "POSTED",
              "timeFrame": "From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years",
              "title": "Duration of Response in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer",
              "type": "SECONDARY",
              "unitOfMeasure": "months"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "8.5",
                          "upperLimit": "13.2",
                          "value": "10.7"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "6.0",
                          "upperLimit": "9.9",
                          "value": "6.8"
                        }
                      ]
                    }
                  ],
                  "title": "BICR: DoR"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "7.0",
                          "upperLimit": "9.9",
                          "value": "8.3"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "3.7",
                          "upperLimit": "6.6",
                          "value": "5.6"
                        }
                      ]
                    }
                  ],
                  "title": "Investigator: DoR"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "373"
                    },
                    {
                      "groupId": "OG001",
                      "value": "184"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first.\nDoR was based on blinded independent central review (BICR) and investigator assessment.\nMedian was from Kaplan-Meier estimate.\nConfidence interval for median was computed using the Brookmeyer-Crowley method.",
              "dispersionType": "95% Confidence Interval",
              "groups": [
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg&#x2F;kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg&#x2F;kg were infused for a minimum of 30 minutes.",
                  "id": "OG000",
                  "title": "Trastuzumab Deruxtecan (T-DXd)"
                },
                {
                  "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician&#x27;s choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.",
                  "id": "OG001",
                  "title": "Physician&#x27;s Choice"
                }
              ],
              "paramType": "MEDIAN",
              "populationDescription": "Duration of response was assessed in the Full Analysis Set.",
              "reportingStatus": "POSTED",
              "timeFrame": "From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years",
              "title": "Duration of Response in Participants With HER2-low Breast Cancer (All Patients)",
              "type": "SECONDARY",
              "unitOfMeasure": "months"
            }
          ]
        },
        "participantFlowModule": {
          "groups": [
            {
              "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg&#x2F;kg was infused for approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg&#x2F;kg were infused for a minimum of 30 minutes.",
              "id": "FG000",
              "title": "Trastuzumab Deruxtecan (T-DXd)"
            },
            {
              "description": "Participants with HER2-low, unresectable, and&#x2F;or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician&#x27;s choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.",
              "id": "FG001",
              "title": "Physician&#x27;s Choice"
            }
          ],
          "periods": [
            {
              "dropWithdraws": [
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "220"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "130"
                    }
                  ],
                  "type": "Progressive disease as per RECIST v1.1"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "60"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "14"
                    }
                  ],
                  "type": "Adverse Event"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "12"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "11"
                    }
                  ],
                  "type": "Withdrawal by Subject"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "10"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "8"
                    }
                  ],
                  "type": "Clinical progression by investigator"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "5"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "2"
                    }
                  ],
                  "type": "Death"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "4"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "3"
                    }
                  ],
                  "type": "Physician Decision"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "2"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "Other"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "1"
                    }
                  ],
                  "type": "Lost to Follow-up"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "2"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "12"
                    }
                  ],
                  "type": "Randomized, but not treated"
                }
              ],
              "milestones": [
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "373"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "184"
                    }
                  ],
                  "type": "STARTED"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "58"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "3"
                    }
                  ],
                  "comment": "Ongoing as of 11 Jan 2022",
                  "type": "COMPLETED"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "315"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "181"
                    }
                  ],
                  "type": "NOT COMPLETED"
                }
              ],
              "title": "Overall Study"
            }
          ],
          "preAssignmentDetails": "All participants had been previously treated with at least 1 and no more than 2 prior lines of chemotherapy in the recurrent or metastatic setting.",
          "recruitmentDetails": "A total of 557 participants were enrolled and randomized to treatment at 161 study sites in the United States (27 study sites), Japan (18 sites), France (16 sites), China (15 sites), Italy (13 sites), Spain (12 sites), Greece (8 sites), Portugal (8 sites), Republic of Korea (8 sites), Israel (6 sites), Switzerland (6 sites), Austria (4 sites), Belgium (4 sites), Russia (3 sites), Sweden (3 sites), Taiwan (3 sites), Unted Kingdom (3 sites), Canada (2 sites), and Hungary (2 sites)."
        }
      }
    },
    {
      "op": "add",
      "path": "/annotationSection",
      "value": {
        "annotationModule": {
          "unpostedAnnotation": {
            "unpostedEvents": [
              {
                "date": "2023-02-09",
                "type": "RESET"
              }
            ],
            "unpostedResponsibleParty": "Daiichi Sankyo, Inc."
          }
        }
      }
    },
    {
      "op": "add",
      "path": "/documentSection",
      "value": {
        "largeDocumentModule": {
          "largeDocs": [
            {
              "date": "2022-10-12",
              "filename": "Prot_SAP_000.pdf",
              "hasIcf": false,
              "hasProtocol": true,
              "hasSap": true,
              "label": "Study Protocol and Statistical Analysis Plan",
              "size": 27169102,
              "typeAbbrev": "Prot_SAP",
              "uploadDate": "2023-01-11T23:51"
            }
          ],
          "reviewUnit": {
            "resetReasons": [
              "The Document Type or Document Date appear inconsistent with information in an uploaded study document."
            ]
          }
        }
      }
    }
  ],
  "provenance": {
    "from_snapshot_hash": "1f9dc53eb5d68175ab0d4c061209772d12c6b0dd3fc15af312c9e6d6251a2069",
    "materiality_event_hash": "15889ff60f21733f094268d442cc8d58547e2131e285632639224d0e61877d4c",
    "patch_hash": "41ca196b320b157d901f92c081c34d92d46b4dfdb428ad32ef06472cbfa780bf",
    "patch_raw_hash": "42b470b86c6464ac37ccd6fbf6ea3cad74469e51be7931d0ab0d2cb61ef0d7e7",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT03734029/history/27?patchToVersion=28",
    "to_snapshot_hash": "be9bef7da47603ccba272d37a7261abda3a43507b62316e0458a7f730a53e180"
  },
  "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/NCT03734029",
    "nct_id": "NCT03734029"
  },
  "versions": {
    "from_version": 27,
    "submitted_date": "2023-01-11",
    "to_version": 28
  }
}