{"changed_paths":["/protocolSection/statusModule/statusVerifiedDate","/protocolSection/statusModule/completionDateStruct/date","/protocolSection/statusModule/lastUpdateSubmitDate","/protocolSection/statusModule/lastUpdatePostDateStruct/date","/protocolSection/statusModule/resultsFirstSubmitQcDate","/protocolSection/statusModule/resultsFirstPostDateStruct","/protocolSection/outcomesModule/secondaryOutcomes/1","/protocolSection/outcomesModule/secondaryOutcomes/1","/protocolSection/outcomesModule/secondaryOutcomes/3","/protocolSection/outcomesModule/secondaryOutcomes/4","/protocolSection/outcomesModule/secondaryOutcomes/5","/protocolSection/outcomesModule/otherOutcomes","/resultsSection/participantFlowModule/periods/0/milestones/1","/resultsSection/participantFlowModule/periods/0/milestones/2","/resultsSection/outcomeMeasuresModule/outcomeMeasures/2","/resultsSection/outcomeMeasuresModule/outcomeMeasures/2","/resultsSection/outcomeMeasuresModule/outcomeMeasures/4","/resultsSection/outcomeMeasuresModule/outcomeMeasures/5","/resultsSection/outcomeMeasuresModule/outcomeMeasures/6","/resultsSection/outcomeMeasuresModule/outcomeMeasures/11","/resultsSection/adverseEventsModule/timeFrame","/resultsSection/adverseEventsModule/description","/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected","/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAtRisk","/resultsSection/adverseEventsModule/eventGroups/1/deathsNumAffected","/resultsSection/adverseEventsModule/eventGroups/1/deathsNumAtRisk","/resultsSection/adverseEventsModule/armsReviewUnit","/resultsSection/adverseEventsModule/allCauseMortalityReviewUnit","/annotationSection","/reviewUnit"],"citation_text":"TrialDiff Evidence Record evt_NCT03734029_v29_v30_3bc3c0a82c88. ClinicalTrials.gov NCT03734029, versions 29-30. Evidence version 1.","claims_not_supported":["That the amendment was scientifically unjustified.","That the change constitutes misconduct or wrongdoing.","That sponsor intent can be inferred from this registry change.","That the change caused or altered the trial's results.","That the change was or was not disclosed in a manuscript.","That TrialDiff determines regulatory compliance or non-compliance.","That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.","That event-class membership is a validated global review-priority ranking."],"claims_supported":["TrialDiff compared ClinicalTrials.gov record version 29 to version 30 for NCT03734029.","The JSON Patch for this comparison has hash 857ff437dce10fafb759508bac550e4a5ce82eb5bec9274441aa707a2084c797.","The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.","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.","The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/secondaryOutcomes/1, /protocolSection/outcomesModule/secondaryOutcomes/1, /protocolSection/outcomesModule/secondaryOutcomes/3, /protocolSection/outcomesModule/secondaryOutcomes/4, /protocolSection/outcomesModule/secondaryOutcomes/5, /protocolSection/outcomesModule/otherOutcomes, /resultsSection/participantFlowModule/periods/0/milestones/1, /resultsSection/participantFlowModule/periods/0/milestones/2, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6, /resultsSection/outcomeMeasuresModule/outcomeMeasures/11, /resultsSection/adverseEventsModule/timeFrame, /resultsSection/adverseEventsModule/description, /resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected, /resultsSection/adverseEventsModule/eventGroups/0/deathsNumAtRisk, /resultsSection/adverseEventsModule/eventGroups/1/deathsNumAffected, /resultsSection/adverseEventsModule/eventGroups/1/deathsNumAtRisk, /resultsSection/adverseEventsModule/armsReviewUnit, /resultsSection/adverseEventsModule/allCauseMortalityReviewUnit, /annotationSection, /reviewUnit.","The timeline value moved by 366 days.","An outcome path changed between versions 29 and 30 in a patch that also carried a hasResults or resultsSection co-occurrence signal."],"classification":{"calibration_status":"uncalibrated","categories":["adverse_event_group_change","timeline_major_slip","results_reconciliation"],"category":"adverse_event_group_change","deterministic_rules":["adverse_event_group_change"],"event_class_rule_set_hash":"07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0","event_classes":["outcome_edit_cooccurs_with_results_posting"],"rule_set_hash":"318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86","severity":"high","severity_pre_timing":"high","timing_context":"late_recruitment","triage_label":"high","triage_rule_set_hash":"af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b","value_signals":[{"category":"timeline_major_slip","date_struct":"completionDateStruct","delta_days":366,"direction":"later","new_precision":"month","new_type":"ESTIMATED","new_value":"2024-03","old_precision":"month","old_type":"ESTIMATED","old_value":"2023-03","path":"/protocolSection/statusModule/completionDateStruct/date","severity":"high","signal":"timeline_major_slip"},{"category":"results_reconciliation","paths":["/protocolSection/outcomesModule/secondaryOutcomes/1","/protocolSection/outcomesModule/secondaryOutcomes/3","/protocolSection/outcomesModule/secondaryOutcomes/4","/protocolSection/outcomesModule/secondaryOutcomes/5"],"severity":"low","signal":"results_reconciliation_outcome_suppression"}]},"event_id":"evt_NCT03734029_v29_v30_3bc3c0a82c88","evidence_version":1,"patch":[{"op":"replace","path":"/protocolSection/statusModule/statusVerifiedDate","value":"2023-05"},{"op":"replace","path":"/protocolSection/statusModule/completionDateStruct/date","value":"2024-03"},{"op":"replace","path":"/protocolSection/statusModule/lastUpdateSubmitDate","value":"2023-05-25"},{"op":"replace","path":"/protocolSection/statusModule/lastUpdatePostDateStruct/date","value":"2023-06-15"},{"op":"add","path":"/protocolSection/statusModule/resultsFirstSubmitQcDate","value":"2023-05-25"},{"op":"add","path":"/protocolSection/statusModule/resultsFirstPostDateStruct","value":{"date":"2023-06-15","type":"ACTUAL"}},{"op":"remove","path":"/protocolSection/outcomesModule/secondaryOutcomes/1"},{"op":"remove","path":"/protocolSection/outcomesModule/secondaryOutcomes/1"},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/3","value":{"description":"Overall 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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.","id":"OG000","title":"Trastuzumab Deruxtecan (T-DXd)"},{"description":"Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician'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's Choice"}],"paramType":"NUMBER","populationDescription":"Overall survival events (deaths) were analyzed in the Full 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on the label approved in each country.\nAs prespecified in the protocol for safety analysis, the PC group was combined for an appropriate sample size for the comparator group."},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected","value":149},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAtRisk","value":373},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/1/deathsNumAffected","value":90},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/1/deathsNumAtRisk","value":184},{"op":"remove","path":"/resultsSection/adverseEventsModule/armsReviewUnit"},{"op":"remove","path":"/resultsSection/adverseEventsModule/allCauseMortalityReviewUnit"},{"op":"remove","path":"/annotationSection"},{"op":"remove","path":"/reviewUnit"}],"provenance":{"from_snapshot_hash":"e2a30ad695d0324f3a2e400ab6af2a1454346505b0d7f475f8e56814d12cae8c","materiality_event_hash":"6c0157028f31ecdde6b145a710291abf30d767580717520839e4503a33ba7ccf","patch_hash":"857ff437dce10fafb759508bac550e4a5ce82eb5bec9274441aa707a2084c797","patch_raw_hash":"108f01e9d79868cd8cf19eddd9e7f2c465e593e5840905e6d1fdbcabcef1822a","patch_source":"ctgov_internal_history","patch_source_url":"https://clinicaltrials.gov/api/int/studies/NCT03734029/history/29?patchToVersion=30","to_snapshot_hash":"e0354115fd9d35ab6fd3c0bc978eaec24bf65f7c3efcc6c9c9d379f6450cfc63"},"review_question":"What 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