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Evidence Record evt_NCT05460273_v13_v14_d165171d8200. ClinicalTrials.gov NCT05460273, versions 13-14. 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 13 to version 14 for NCT05460273.","The JSON Patch for this comparison has hash 6a19d41ff9741e529371b4e0f2c81e08cc84406ef0167c0a5dfd26856bccfaed.","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.","A registry path under serious adverse event results was added between ClinicalTrials.gov versions 13 and 14.","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, serious_adverse_event_addition, serious_adverse_event_modification.","The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, 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/resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/0/measurements/0/value, /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/0/measurements/1/value, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/1/value, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/1/upperLimit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/1/comment, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/1/value, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/1/upperLimit, 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/resultsSection/outcomeMeasuresModule/outcomeMeasures/18/denoms/0/counts/1/value, /resultsSection/outcomeMeasuresModule/outcomeMeasures/18/classes/0/categories/0/measurements/0/value, /resultsSection/outcomeMeasuresModule/outcomeMeasures/18/classes/0/categories/0/measurements/0/lowerLimit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/18/classes/0/categories/0/measurements/1/value, /resultsSection/outcomeMeasuresModule/outcomeMeasures/18/classes/0/categories/0/measurements/1/lowerLimit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/19/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/19/groups/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/19/denoms/0/counts/0/value, /resultsSection/outcomeMeasuresModule/outcomeMeasures/19/denoms/0/counts/1/value, /resultsSection/outcomeMeasuresModule/outcomeMeasures/19/classes/0/categories/0/measurements/0/value, 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/resultsSection/outcomeMeasuresModule/outcomeMeasures/20/classes/0/categories/0/measurements/1/lowerLimit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/21/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/21/groups/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/22/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/22/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/22/groups/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/22/classes/0/categories/0/measurements/1/upperLimit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/22/classes/0/categories/0/measurements/1/comment, /resultsSection/adverseEventsModule/timeFrame, /resultsSection/adverseEventsModule/eventGroups/0/title, /resultsSection/adverseEventsModule/eventGroups/0/description, /resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected, /resultsSection/adverseEventsModule/eventGroups/0/deathsNumAtRisk, 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cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/10/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/11/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/12/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/13/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/14/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/15/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/16/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/17/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/18/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/19/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/20/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/21/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/participantFlowModule/preAssignmentDetails","value":"Overall 168 participants were screened at 23 centers in China.\nA total of 119 participants were treated with Dato-DXd.\nFor TNBC cohort, 106 participant was screened at 14 centers in China.\n79 participants received Dato-DXd at the 14 centers.\nFor NSCLC cohort, 62 participant was screened at 12 centers in China.\n40 participants received Dato-DXd at 11 centers.\nNote: 3 centers screened both TNBC participants and NSCLC participants."},{"op":"replace","path":"/resultsSection/participantFlowModule/recruitmentDetails","value":"This Phase 1/2, open-label, multiple-cohort, single-arm study was conducted in participants with Advanced Non-Small-Cell Lung Cancer (NSCLC) and Triple-Negative Breast Cancer(TNBC) in China.\nFor TNBC cohort, first participant was screened on 11Jul2022, last participant was screened on 27Apr2023.\nFor NSCLC cohort, first participant was screened on 29Aug2022, last participant was screened on 21Mar2023."},{"op":"replace","path":"/resultsSection/participantFlowModule/groups/0/title","value":"Dato-DXd_NSCLC"},{"op":"replace","path":"/resultsSection/participantFlowModule/groups/0/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/participantFlowModule/groups/1/title","value":"Dato-DXd_TNBC"},{"op":"replace","path":"/resultsSection/participantFlowModule/groups/1/description","value":"Final Analysis with DCO on 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NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription","value":"FAS: Enrolled participants who have received at least one dose of treatment.\nThe analysis for DOR assessed by investigator was based on the responders in the FAS of each cohort."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/1/value","value":"8.1"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/1/upperLimit","value":"11.2"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/1/comment"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/populationDescription","value":"RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR.\nThe analysis for TTR assessed by ICR was based on the responders in the RES of each cohort."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/1/value","value":"8.0"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/1/upperLimit","value":"10.8"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/1/comment"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/classes/0/categories/0/measurements/0/comment","value":"Upper limit not reached"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/classes/0/categories/0/measurements/1/value","value":"16.7"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/classes/0/categories/0/measurements/1/lowerLimit","value":"13.8"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/classes/0/categories/0/measurements/1/upperLimit","value":"20.4"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/classes/0/categories/0/measurements/1/comment"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/classes/0/categories/0/measurements/1/upperLimit","value":"9.5"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/10/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/10/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/10/classes/1/categories/0/measurements/1/value","value":"32.5"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/11/populationDescription","value":"FAS: Enrolled participants who have received at least one dose of treatment.\nParticipants who were enrolled but did not subsequently receive study intervention are not included in the analysis.\nThe analysis for TTR assessed by investigator was based on the responders in the FAS of each cohort."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/11/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/11/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/12/populationDescription","value":"PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd.\nThe analysis for AUC was based on the patients with intensive PK collection of each cohort."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/12/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/12/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/13/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/13/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/13/denoms/0/counts/0/value","value":"8"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/13/denoms/0/counts/1/value","value":"9"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/13/classes/0/categories/0/measurements/0/value","value":"151.1"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/13/classes/0/categories/0/measurements/0/spread","value":"11.62"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/13/classes/0/categories/0/measurements/1/value","value":"115.5"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/13/classes/0/categories/0/measurements/1/spread","value":"22.99"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/14/populationDescription","value":"PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd.\nThe analysis for AUC was based on the patients with intensive PK collection of each cohort."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/14/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/14/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/15/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/15/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/15/denoms/0/counts/0/value","value":"8"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/15/denoms/0/counts/1/value","value":"9"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/15/classes/0/categories/0/measurements/0/value","value":"150.9"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/15/classes/0/categories/0/measurements/0/spread","value":"12.73"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/15/classes/0/categories/0/measurements/1/value","value":"108.7"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/15/classes/0/categories/0/measurements/1/spread","value":"11.30"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/16/populationDescription","value":"PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd.\nThe analysis for AUC was based on the patients with intensive PK collection of each cohort."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/16/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/16/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/17/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/17/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/17/denoms/0/counts/0/value","value":"8"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/17/denoms/0/counts/1/value","value":"9"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/17/classes/0/categories/0/measurements/0/value","value":"2.976"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/17/classes/0/categories/0/measurements/0/spread","value":"25.84"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/17/classes/0/categories/0/measurements/1/value","value":"2.231"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/17/classes/0/categories/0/measurements/1/spread","value":"27.51"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/18/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/18/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/18/denoms/0/counts/0/value","value":"8"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/18/denoms/0/counts/1/value","value":"9"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/18/classes/0/categories/0/measurements/0/value","value":"4.87"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/18/classes/0/categories/0/measurements/0/lowerLimit","value":"1.55"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/18/classes/0/categories/0/measurements/1/value","value":"1.58"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/18/classes/0/categories/0/measurements/1/lowerLimit","value":"1.38"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/19/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/19/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/19/denoms/0/counts/0/value","value":"8"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/19/denoms/0/counts/1/value","value":"9"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/19/classes/0/categories/0/measurements/0/value","value":"4.95"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/19/classes/0/categories/0/measurements/0/lowerLimit","value":"1.83"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/19/classes/0/categories/0/measurements/1/value","value":"1.63"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/19/classes/0/categories/0/measurements/1/lowerLimit","value":"1.38"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/20/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/20/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/20/denoms/0/counts/0/value","value":"8"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/20/denoms/0/counts/1/value","value":"9"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/20/classes/0/categories/0/measurements/0/value","value":"6.09"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/20/classes/0/categories/0/measurements/0/lowerLimit","value":"4.87"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/20/classes/0/categories/0/measurements/1/value","value":"22.52"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/20/classes/0/categories/0/measurements/1/lowerLimit","value":"6.85"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/21/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/21/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/22/populationDescription","value":"RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR.\nThe analysis for DOR assessed by ICR was based on the responders in the RES of each cohort."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/22/timeFrame","value":"TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/22/groups/1/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/22/classes/0/categories/0/measurements/1/upperLimit","value":"9.4"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/22/classes/0/categories/0/measurements/1/comment"},{"op":"replace","path":"/resultsSection/adverseEventsModule/timeFrame","value":"Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort."},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/0/title","value":"Dato-DXd_NSCLC"},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/0/description","value":"Final Analysis with DCO on 27Nov2024"},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected","value":27},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAtRisk","value":40},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/0/seriousNumAffected","value":12},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/0/seriousNumAtRisk","value":40},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/0/otherNumAffected","value":38},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/0/otherNumAtRisk","value":40},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/1/title","value":"Dato-DXd_TNBC"},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/1/description","value":"Final Analysis with DCO on 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