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Evidence Record evt_NCT02340221_v62_v63_5d3309fece04. ClinicalTrials.gov NCT02340221, versions 62-63. 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 TrialDiff determines whether the stopped-trial explanation satisfies 42 CFR 11.64.","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 62 to version 63 for NCT02340221.","The JSON Patch for this comparison has hash aed0373559cde1269ae3d15d3e52bd59c1dfa893fbe4a50f692a8ba180e1b02d.","The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.","The deterministic triage label was high; before timing adjustment it was high.","The triage label is uncalibrated metadata, not a validated review-priority finding.","The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting.","A registry field under the status or stopped-trial explanation module changed between ClinicalTrials.gov versions 62 and 63.","The timing context for the from-version record was post_recruitment.","The deterministic rules that fired were: adverse_event_group_change, other_adverse_event_addition, other_adverse_event_modification, serious_adverse_event_addition, serious_adverse_event_modification, terminal_status_change, why_stopped_change.","The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/overallStatus, /protocolSection/statusModule/primaryCompletionDateStruct/date, 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Sponsor discontinued the manufacturing and development of taselisib due to modest clinical benefit and limited tolerability."},{"op":"replace","path":"/protocolSection/outcomesModule/primaryOutcomes/0/measure","value":"Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis"},{"op":"add","path":"/protocolSection/outcomesModule/primaryOutcomes/1","value":{"description":"PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier.\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was 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