{"changed_paths":["/protocolSection/statusModule/statusVerifiedDate","/protocolSection/statusModule/completionDateStruct/date","/protocolSection/statusModule/lastUpdateSubmitDate","/protocolSection/statusModule/lastUpdatePostDateStruct/date","/protocolSection/statusModule/resultsFirstSubmitDate","/protocolSection/statusModule/resultsFirstSubmitQcDate","/protocolSection/statusModule/resultsFirstPostDateStruct","/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/measure","/protocolSection/outcomesModule/secondaryOutcomes/4/description","/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/5/measure","/protocolSection/outcomesModule/secondaryOutcomes/5/description","/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/7/measure","/protocolSection/outcomesModule/secondaryOutcomes/7/description","/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/8/measure","/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/8/description","/protocolSection/outcomesModule/secondaryOutcomes/9/measure","/protocolSection/outcomesModule/secondaryOutcomes/9/description","/protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/10/measure","/protocolSection/outcomesModule/secondaryOutcomes/10/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/10/description","/protocolSection/outcomesModule/secondaryOutcomes/11/measure","/protocolSection/outcomesModule/secondaryOutcomes/11/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/11/description","/protocolSection/outcomesModule/secondaryOutcomes/12/measure","/protocolSection/outcomesModule/secondaryOutcomes/12/description","/protocolSection/outcomesModule/secondaryOutcomes/12/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/13","/protocolSection/outcomesModule/secondaryOutcomes/14","/protocolSection/outcomesModule/secondaryOutcomes/15","/protocolSection/outcomesModule/secondaryOutcomes/16","/protocolSection/outcomesModule/secondaryOutcomes/17","/protocolSection/outcomesModule/secondaryOutcomes/18","/protocolSection/outcomesModule/secondaryOutcomes/19","/protocolSection/outcomesModule/secondaryOutcomes/20","/protocolSection/outcomesModule/secondaryOutcomes/21","/protocolSection/outcomesModule/otherOutcomes","/protocolSection/contactsLocationsModule/locations/3/zip","/protocolSection/referencesModule","/annotationSection","/hasResults","/resultsSection","/documentSection"],"citation_text":"TrialDiff Evidence Record evt_NCT05460273_v12_v13_dfa2afd690c4. ClinicalTrials.gov NCT05460273, versions 12-13. 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 12 to version 13 for NCT05460273.","The JSON Patch for this comparison has hash e5f313ea4b399b78b6f6b9aaeff7f8c3a92dbe37c3fa1b103abfb0e69eb97994.","The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.","The deterministic triage label was high; before timing 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/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/measure, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/5/measure, /protocolSection/outcomesModule/secondaryOutcomes/5/description, /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/7/measure, /protocolSection/outcomesModule/secondaryOutcomes/7/description, /protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/8/measure, /protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/8/description, /protocolSection/outcomesModule/secondaryOutcomes/9/measure, /protocolSection/outcomesModule/secondaryOutcomes/9/description, /protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/10/measure, /protocolSection/outcomesModule/secondaryOutcomes/10/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/10/description, /protocolSection/outcomesModule/secondaryOutcomes/11/measure, /protocolSection/outcomesModule/secondaryOutcomes/11/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/11/description, /protocolSection/outcomesModule/secondaryOutcomes/12/measure, /protocolSection/outcomesModule/secondaryOutcomes/12/description, /protocolSection/outcomesModule/secondaryOutcomes/12/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/13, /protocolSection/outcomesModule/secondaryOutcomes/14, /protocolSection/outcomesModule/secondaryOutcomes/15, /protocolSection/outcomesModule/secondaryOutcomes/16, /protocolSection/outcomesModule/secondaryOutcomes/17, /protocolSection/outcomesModule/secondaryOutcomes/18, /protocolSection/outcomesModule/secondaryOutcomes/19, /protocolSection/outcomesModule/secondaryOutcomes/20, /protocolSection/outcomesModule/secondaryOutcomes/21, /protocolSection/outcomesModule/otherOutcomes, /protocolSection/contactsLocationsModule/locations/3/zip, /protocolSection/referencesModule, /annotationSection, /hasResults, /resultsSection, /documentSection.","The timeline value moved by 366 days.","An outcome path changed between versions 12 and 13 in a patch that also carried a hasResults or resultsSection co-occurrence signal."],"classification":{"calibration_status":"uncalibrated","categories":["timeline_major_slip","results_reconciliation"],"category":"timeline_major_slip","deterministic_rules":[],"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":"day","new_type":"ESTIMATED","new_value":"2025-12-31","old_precision":"day","old_type":"ESTIMATED","old_value":"2024-12-30","path":"/protocolSection/statusModule/completionDateStruct/date","severity":"high","signal":"timeline_major_slip"},{"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/10/description","/protocolSection/outcomesModule/secondaryOutcomes/10/measure","/protocolSection/outcomesModule/secondaryOutcomes/10/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/11/description","/protocolSection/outcomesModule/secondaryOutcomes/11/measure","/protocolSection/outcomesModule/secondaryOutcomes/11/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/12/description","/protocolSection/outcomesModule/secondaryOutcomes/12/measure","/protocolSection/outcomesModule/secondaryOutcomes/12/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/13","/protocolSection/outcomesModule/secondaryOutcomes/14","/protocolSection/outcomesModule/secondaryOutcomes/15","/protocolSection/outcomesModule/secondaryOutcomes/16","/protocolSection/outcomesModule/secondaryOutcomes/17","/protocolSection/outcomesModule/secondaryOutcomes/18","/protocolSection/outcomesModule/secondaryOutcomes/19","/protocolSection/outcomesModule/secondaryOutcomes/2/description","/protocolSection/outcomesModule/secondaryOutcomes/2/measure","/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/20","/protocolSection/outcomesModule/secondaryOutcomes/21","/protocolSection/outcomesModule/secondaryOutcomes/3/description","/protocolSection/outcomesModule/secondaryOutcomes/3/measure","/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/4/description","/protocolSection/outcomesModule/secondaryOutcomes/4/measure","/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/5/description","/protocolSection/outcomesModule/secondaryOutcomes/5/measure","/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/7/description","/protocolSection/outcomesModule/secondaryOutcomes/7/measure","/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/8/description","/protocolSection/outcomesModule/secondaryOutcomes/8/measure","/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/9/description","/protocolSection/outcomesModule/secondaryOutcomes/9/measure","/protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame"],"severity":"low","signal":"results_reconciliation_outcome_suppression"}]},"event_id":"evt_NCT05460273_v12_v13_dfa2afd690c4","evidence_version":1,"patch":[{"op":"replace","path":"/protocolSection/statusModule/statusVerifiedDate","value":"2025-05"},{"op":"replace","path":"/protocolSection/statusModule/completionDateStruct/date","value":"2025-12-31"},{"op":"replace","path":"/protocolSection/statusModule/lastUpdateSubmitDate","value":"2025-06-12"},{"op":"replace","path":"/protocolSection/statusModule/lastUpdatePostDateStruct/date","value":"2025-06-13"},{"op":"add","path":"/protocolSection/statusModule/resultsFirstSubmitDate","value":"2024-10-31"},{"op":"add","path":"/protocolSection/statusModule/resultsFirstSubmitQcDate","value":"2025-06-12"},{"op":"add","path":"/protocolSection/statusModule/resultsFirstPostDateStruct","value":{"date":"2025-06-13","type":"ACTUAL"}},{"op":"replace","path":"/protocolSection/outcomesModule/primaryOutcomes/0/measure","value":"Confirmed Objective Response Rate(ORR) Assessed by Independent Central Review(ICR)"},{"op":"replace","path":"/protocolSection/outcomesModule/primaryOutcomes/0/description","value":"Confirmed ORR is defined as the proportion of participants in each cohort who have a confirmed CR or confirmed PR, as assessed by ICR per RECIST 1.1."},{"op":"replace","path":"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame","value":"TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/0/measure","value":"Confirmed Objective Response Rate(ORR) Assessed by Investigator"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/0/description","value":"Confirmed ORR is defined as the proportion of participants in each cohort who have a confirmed CR or confirmed PR, as determined by investigator assessment per RECIST 1.1."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame","value":"TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/1/measure","value":"Duration of Response (DoR), Assessed by Investigator"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/1/description","value":"Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by investgator, or death due to any cause."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame","value":"TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/2/measure","value":"Disease Control Rate (DCR), Assessed by ICR"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/2/description","value":"Disease control rate is defined as the percentage of participants who have a confirmed CR or PR or who have SD per RECIST 1.1, as assessed by ICR"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame","value":"TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/3/measure","value":"Best Overall Response (BoR) , Assessed by ICR"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/3/description","value":"Best overall response is defined as participant&#x27;s best confirmed response during their participation in the study, but prior to starting any subsequent anticancer therapy, up until RECIST 1.1-defined PD or the last evaluable assessment in the absence of RECIST 1.1-defined progression."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame","value":"TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/4/measure","value":"Time To Response (TTR) , Assessed by ICR"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/4/description","value":"Time to response is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame","value":"TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. 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NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame","value":"TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/7/measure","value":"Progression-Free Survival (PFS) , Assessed by Investigator"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/7/description","value":"Progression-free survival is defined as time from the date of the first dose of study intervention until progression per RECIST 1.1, as assessed by investigator, or death due to any cause."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame","value":"TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/8/measure","value":"Disease Control Rate (DCR), Assessed by Investigator"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame","value":"TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up."},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/8/description","value":"Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by investigator, or death due to any cause."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/9/measure","value":"Best Overall Response (BoR) , Assessed by Investigator"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/9/description","value":"Best overall response is defined as participant&#x27;s best confirmed response during their participation in the study, but prior to starting any subsequent anticancer therapy, up until RECIST 1.1-defined PD or the last evaluable assessment in the absence of RECIST 1.1-defined progression."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame","value":"TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/10/measure","value":"Time To Response (TTR) , Assessed by Investigator"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/10/timeFrame","value":"TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up."},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/10/description","value":"Time to response is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/11/measure","value":"Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _ Total Anti-TROP2 Antibody"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/11/timeFrame","value":"TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. 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NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.","title":"Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _ MAAA-1181a","type":"SECONDARY","unitOfMeasure":"Hour"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"33.3"},{"groupId":"OG001","value":"36.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"38"}],"units":"Participants"}],"description":"The prevalence of ADA (positive at any visit)","groups":[{"description":"Final Analysis with DCO on 06May2024","id":"OG000","title":"TNBC Cohort"},{"description":"Primary Analysis with DCO on 09Oct2023","id":"OG001","title":"NSCLC Cohort"}],"paramType":"NUMBER","populationDescription":"ADA Evaluable Set: Participants in the FAS with a non-missing baseline Dato-DXd ADA result and at least one post-baseline Dato-DXd ADA result.","reportingStatus":"POSTED","timeFrame":"TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.","title":"Immunogenicity of Dato-DXd","type":"SECONDARY","unitOfMeasure":"percentage"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.53","upperLimit":"12.6","value":"6.7"},{"comment":"The upper limit is not calculable due to insufficient number of participants with events","groupId":"OG001","lowerLimit":"5.9","upperLimit":"NA","value":"8.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"description":"Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by ICR, or death due to any cause.","dispersionType":"95% Confidence Interval","groups":[{"description":"Final Analysis with DCO on 06May2024","id":"OG000","title":"TNBC Cohort"},{"description":"Primary Analysis with DCO on 09Oct2023","id":"OG001","title":"NSCLC Cohort"}],"paramType":"MEDIAN","populationDescription":"<p>RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR.</p><p>The analysis for DOR assessed by ICR was based on the responders in the RES of each cohort.</p>","reportingStatus":"POSTED","timeFrame":"TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.","title":"Duration of Response (DoR), Assessed by ICR","type":"SECONDARY","unitOfMeasure":"Month"}]},"participantFlowModule":{"groups":[{"description":"Final Analysis with DCO on 06May2024","id":"FG000","title":"TNBC Cohort"},{"description":"Primary Analysis with DCO on 09Oct2023","id":"FG001","title":"NSCLC Cohort"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"9"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"31"}],"type":"Ongoing participants at NSCLC primary analysis DCO"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"79"},{"groupId":"FG001","numSubjects":"40"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"29"},{"comment":"NSCLC cohort has not reached final analysis.","groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"50"},{"groupId":"FG001","numSubjects":"40"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"<p>Overall 168 participants were screened at 23 centers in China.\nA total of 119 participants were treated with Dato-DXd.</p><ul><li>For TNBC cohort, 106 participant was screened at 14 centers in China.\n79 participants received Dato-DXd at the 14 centers.</li><li>For NSCLC cohort, 62 participant was screened at 12 centers in China.\n40 participants received Dato-DXd at 11 centers.</li></ul><p>Note: 3 centers screened both TNBC participants and NSCLC participants.</p>","recruitmentDetails":"<p>This Phase 1&#x2F;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.</p><ul><li>For TNBC cohort, first participant was screened on 11Jul2022, last participant was screened on 27Apr2023.</li><li>For NSCLC cohort, first participant was screened on 29Aug2022, last participant was screened on 21Mar2023.</li></ul>"}}},{"op":"add","path":"/documentSection","value":{"largeDocumentModule":{"largeDocs":[{"date":"2023-05-29","filename":"Prot_000.pdf","hasIcf":false,"hasProtocol":true,"hasSap":false,"label":"Study Protocol","size":7732633,"typeAbbrev":"Prot","uploadDate":"2024-10-31T06:24"},{"date":"2023-08-30","filename":"SAP_001.pdf","hasIcf":false,"hasProtocol":false,"hasSap":true,"label":"Statistical Analysis Plan","size":1210633,"typeAbbrev":"SAP","uploadDate":"2024-10-31T06:24"}]}}}],"provenance":{"from_snapshot_hash":"72a84ceaa059f5c1daebdade79a5ec3c571cbafbb98b01bf01f6c54fc8e77419","materiality_event_hash":"c438c995d5f02be0189bbdd59b57f38e50df33c49ed836fae98b37171efe4dc1","patch_hash":"e5f313ea4b399b78b6f6b9aaeff7f8c3a92dbe37c3fa1b103abfb0e69eb97994","patch_raw_hash":"2e8dfc15f241a9743504ddd8f13c93376de7f9339908fb8483492b03eea5899d","patch_source":"ctgov_internal_history","patch_source_url":"https://clinicaltrials.gov/api/int/studies/NCT05460273/history/12?patchToVersion=13","to_snapshot_hash":"ec92f0704c8a60519f29ccf857bba23d190bfe92784c63b5131d58aed3d989b2"},"review_question":"What explains the major timeline movement, and does the amendment represent a delay, a backfill, or a correction?","schema":"trialdiff.evidence_record","trial":{"clinicaltrials_gov_url":"https://clinicaltrials.gov/study/NCT05460273","nct_id":"NCT05460273"},"versions":{"from_version":12,"submitted_date":"2025-06-12","to_version":13}}