evt_NCT03734029_v28_v29_894aa7cb59a0

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/6/description",
    "/resultsSection/participantFlowModule/preAssignmentDetails",
    "/resultsSection/participantFlowModule/groups/0/description",
    "/resultsSection/baselineCharacteristicsModule/groups/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/paramType",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/measureCategoriesReviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/paramType",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/measureCategoriesReviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/10/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/11/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/measureCategoriesReviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/groups/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/classes/10/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/classes/11/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/measureCategoriesReviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/groups/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/groups/0/description",
    "/resultsSection/adverseEventsModule/description",
    "/resultsSection/adverseEventsModule/eventGroups/0/description",
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    "/resultsSection/adverseEventsModule/otherEvents/0/stats/0/numAffected",
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    "/resultsSection/adverseEventsModule/otherEvents/5/stats/0/numAffected",
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    "/resultsSection/adverseEventsModule/otherEvents/16/stats/0/numAffected",
    "/resultsSection/adverseEventsModule/otherEvents/17/stats/1/numAffected",
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    "/resultsSection/adverseEventsModule/otherEvents/19/stats/0/numAffected",
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    "/resultsSection/adverseEventsModule/otherEvents/21/stats/1/numAffected",
    "/resultsSection/adverseEventsModule/otherEvents/24/stats/0/numAffected",
    "/resultsSection/adverseEventsModule/otherEvents/25/stats/0/numAffected",
    "/resultsSection/adverseEventsModule/otherEvents/28/stats/0/numAffected",
    "/resultsSection/adverseEventsModule/otherEvents/32/stats/0/numAffected",
    "/resultsSection/adverseEventsModule/otherEvents/36/stats/0/numAffected",
    "/resultsSection/adverseEventsModule/otherEvents/39/stats/0/numAffected",
    "/resultsSection/adverseEventsModule/otherEvents/47/stats/0/numAffected",
    "/resultsSection/adverseEventsModule/otherEvents/47/stats/1/numAffected",
    "/resultsSection/adverseEventsModule/otherEvents/48/stats/0/numAffected",
    "/resultsSection/adverseEventsModule/otherEvents/49/stats/0/numAffected",
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    "/documentSection/largeDocumentModule/largeDocs/0/date",
    "/documentSection/largeDocumentModule/reviewUnit",
    "/reviewUnit"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT03734029_v28_v29_894aa7cb59a0. ClinicalTrials.gov NCT03734029, versions 28-29. 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 28 to version 29 for NCT03734029.",
    "The JSON Patch for this comparison has hash 0b2db3c992caea5bef394c885d668010c00833388e0c7f37739350f661af8a82.",
    "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.",
    "The timing context for the from-version record was late_recruitment.",
    "The deterministic rules that fired were: adverse_event_group_change, other_adverse_event_modification, other_adverse_event_removal.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/5/description, /protocolSection/outcomesModule/secondaryOutcomes/6/description, /resultsSection/participantFlowModule/preAssignmentDetails, /resultsSection/participantFlowModule/groups/0/description, /resultsSection/baselineCharacteristicsModule/groups/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/paramType, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/paramType, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/10/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/11/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/groups/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/classes/10/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/classes/11/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/8/groups/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/9/groups/0/description, /resultsSection/adverseEventsModule/description, /resultsSection/adverseEventsModule/eventGroups/0/description, /resultsSection/adverseEventsModule/eventGroups/0/otherNumAffected, /resultsSection/adverseEventsModule/eventGroups/1/otherNumAffected, /resultsSection/adverseEventsModule/otherEvents/0/stats/0/numAffected, /resultsSection/adverseEventsModule/otherEvents/0/stats/1/numAffected, /resultsSection/adverseEventsModule/otherEvents/1/stats/1/numAffected, /resultsSection/adverseEventsModule/otherEvents/3/stats/0/numAffected, /resultsSection/adverseEventsModule/otherEvents/4/stats/0/numAffected, /resultsSection/adverseEventsModule/otherEvents/5/stats/0/numAffected, /resultsSection/adverseEventsModule/otherEvents/14/stats/1/numAffected, /resultsSection/adverseEventsModule/otherEvents/15/stats/0/numAffected, /resultsSection/adverseEventsModule/otherEvents/16/stats/0/numAffected, /resultsSection/adverseEventsModule/otherEvents/17/stats/1/numAffected, /resultsSection/adverseEventsModule/otherEvents/18/stats/0/numAffected, /resultsSection/adverseEventsModule/otherEvents/19/stats/0/numAffected, /resultsSection/adverseEventsModule/otherEvents/20, /resultsSection/adverseEventsModule/otherEvents/21/stats/1/numAffected, /resultsSection/adverseEventsModule/otherEvents/24/stats/0/numAffected, /resultsSection/adverseEventsModule/otherEvents/25/stats/0/numAffected, /resultsSection/adverseEventsModule/otherEvents/28/stats/0/numAffected, /resultsSection/adverseEventsModule/otherEvents/32/stats/0/numAffected, /resultsSection/adverseEventsModule/otherEvents/36/stats/0/numAffected, /resultsSection/adverseEventsModule/otherEvents/39/stats/0/numAffected, /resultsSection/adverseEventsModule/otherEvents/47/stats/0/numAffected, /resultsSection/adverseEventsModule/otherEvents/47/stats/1/numAffected, /resultsSection/adverseEventsModule/otherEvents/48/stats/0/numAffected, /resultsSection/adverseEventsModule/otherEvents/49/stats/0/numAffected, /resultsSection/adverseEventsModule/otherEvents/50, /annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date, /annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/1, /annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/2, /documentSection/largeDocumentModule/largeDocs/0/date, /documentSection/largeDocumentModule/reviewUnit, /reviewUnit.",
    "An outcome path changed between versions 28 and 29 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "adverse_event_group_change",
      "other_adverse_event_removal",
      "other_adverse_event_modification",
      "results_reconciliation"
    ],
    "category": "adverse_event_group_change",
    "deterministic_rules": [
      "adverse_event_group_change",
      "other_adverse_event_modification",
      "other_adverse_event_removal"
    ],
    "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/secondaryOutcomes/0/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/6/description"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT03734029_v28_v29_894aa7cb59a0",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2023-02"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2023-02-15"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2023-03-14"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "value": "Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed 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/secondaryOutcomes/0/description",
      "value": "Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed 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/3/description",
      "value": "Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed 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 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/4/description",
      "value": "Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed 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 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."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
      "value": "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.\nConfirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/6/description",
      "value": "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.\nConfirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment."
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/preAssignmentDetails",
      "value": "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.\nThe treatment chosen for the Physician's Choice arm was based on the label approved in the country of drug administration.\nThe Physician's Choice group was combined to ensure an appropriate sample size for the comparator group."
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/groups/0/description",
      "value": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes."
    },
    {
      "op": "replace",
      "path": "/resultsSection/baselineCharacteristicsModule/groups/0/description",
      "value": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description",
      "value": "Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed 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": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/0/description",
      "value": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description",
      "value": "Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed 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": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/0/description",
      "value": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/0/description",
      "value": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/0/description",
      "value": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/description",
      "value": "Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed 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 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": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/paramType",
      "value": "MEDIAN"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/0/description",
      "value": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/measureCategoriesReviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description",
      "value": "Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed 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 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."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/paramType",
      "value": "MEDIAN"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/0/description",
      "value": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/measureCategoriesReviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/description",
      "value": "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.\nConfirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/0/description",
      "value": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/10/title",
      "value": "BICR: Confirmed Objective response rate"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/11/title",
      "value": "Investigator: Confirmed Objective response rate"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/measureCategoriesReviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/description",
      "value": "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.\nConfirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/groups/0/description",
      "value": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/classes/10/title",
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    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/classes/11/title",
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    },
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    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/groups/0/description",
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    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/groups/0/description",
      "value": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes."
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/description",
      "value": "Safety events were assessed in the Safety Analysis Set, participants who received ≥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.\nThe treatment of Physician's Choice arm was based on the label approved in the country of drug administration.\nThe Physician's Choice group was combined for an appropriate sample size for the comparator group."
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/0/description",
      "value": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes."
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/0/otherNumAffected",
      "value": 366
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/1/otherNumAffected",
      "value": 167
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/0/stats/0/numAffected",
      "value": 137
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/0/stats/1/numAffected",
      "value": 44
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/1/stats/1/numAffected",
      "value": 29
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/3/stats/0/numAffected",
      "value": 281
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/4/stats/0/numAffected",
      "value": 148
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/5/stats/0/numAffected",
      "value": 124
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/14/stats/1/numAffected",
      "value": 49
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/15/stats/0/numAffected",
      "value": 69
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/16/stats/0/numAffected",
      "value": 42
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/17/stats/1/numAffected",
      "value": 10
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/18/stats/0/numAffected",
      "value": 24
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/19/stats/0/numAffected",
      "value": 27
    },
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    },
    {
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      "value": 61
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/24/stats/0/numAffected",
      "value": 72
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/25/stats/0/numAffected",
      "value": 59
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/28/stats/0/numAffected",
      "value": 25
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    {
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      "path": "/resultsSection/adverseEventsModule/otherEvents/32/stats/0/numAffected",
      "value": 38
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/36/stats/0/numAffected",
      "value": 33
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/39/stats/0/numAffected",
      "value": 53
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/47/stats/0/numAffected",
      "value": 34
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/47/stats/1/numAffected",
      "value": 14
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/48/stats/0/numAffected",
      "value": 35
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/49/stats/0/numAffected",
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      "path": "/resultsSection/adverseEventsModule/otherEvents/50"
    },
    {
      "op": "replace",
      "path": "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date",
      "value": "2023-03-13"
    },
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      "value": {
        "date": "2023-03-16",
        "type": "RELEASE"
      }
    },
    {
      "op": "add",
      "path": "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/2",
      "value": {
        "date": "2023-04-10",
        "type": "RESET"
      }
    },
    {
      "op": "replace",
      "path": "/documentSection/largeDocumentModule/largeDocs/0/date",
      "value": "2020-10-12"
    },
    {
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    },
    {
      "op": "add",
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      "value": {
        "resetReasons": [
          "Issues noted on a previous submission of this record do not appear to have been addressed."
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    "patch_source": "ctgov_internal_history",
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    "to_snapshot_hash": "e2a30ad695d0324f3a2e400ab6af2a1454346505b0d7f475f8e56814d12cae8c"
  },
  "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": {
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    "submitted_date": "2023-02-15",
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}