{"changed_paths":["/protocolSection/identificationModule/officialTitle","/protocolSection/statusModule/statusVerifiedDate","/protocolSection/statusModule/startDateStruct/date","/protocolSection/statusModule/startDateStruct/type","/protocolSection/statusModule/completionDateStruct/date","/protocolSection/statusModule/completionDateStruct/type","/protocolSection/statusModule/lastUpdateSubmitDate","/protocolSection/statusModule/lastUpdatePostDateStruct/date","/protocolSection/statusModule/lastUpdatePostDateStruct/type","/protocolSection/statusModule/primaryCompletionDateStruct","/protocolSection/sponsorCollaboratorsModule/responsibleParty","/protocolSection/designModule/designInfo/allocation","/protocolSection/designModule/enrollmentInfo/count","/protocolSection/designModule/enrollmentInfo/type","/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels","/protocolSection/armsInterventionsModule/interventions/0/otherNames","/protocolSection/armsInterventionsModule/interventions/1","/protocolSection/armsInterventionsModule/interventions/1","/protocolSection/armsInterventionsModule/armGroups","/protocolSection/outcomesModule/primaryOutcomes/0/description","/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/0/description","/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/1/description","/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/2/description","/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/3/description","/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/4/description","/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/5/description","/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame","/protocolSection/contactsLocationsModule/overallOfficials/0/name","/protocolSection/contactsLocationsModule/overallOfficials/0/affiliation","/protocolSection/contactsLocationsModule/overallOfficials/0/role","/protocolSection/contactsLocationsModule/overallOfficials/1/name","/protocolSection/contactsLocationsModule/overallOfficials/1/affiliation","/protocolSection/contactsLocationsModule/overallOfficials/1/role","/protocolSection/contactsLocationsModule/locations/0/facility","/protocolSection/contactsLocationsModule/locations/0/city","/protocolSection/contactsLocationsModule/locations/0/state","/protocolSection/contactsLocationsModule/locations/0/zip","/protocolSection/contactsLocationsModule/locations/0/geoPoint/lat","/protocolSection/contactsLocationsModule/locations/0/geoPoint/lon","/protocolSection/contactsLocationsModule/locations/1","/protocolSection/contactsLocationsModule/locations/2","/protocolSection/contactsLocationsModule/locations/3","/protocolSection/contactsLocationsModule/locations/4","/protocolSection/contactsLocationsModule/locations/5","/protocolSection/contactsLocationsModule/locations/6","/protocolSection/contactsLocationsModule/locations/7","/protocolSection/contactsLocationsModule/locations/8","/protocolSection/contactsLocationsModule/locations/9"],"citation_text":"TrialDiff Evidence Record evt_NCT00128856_v1_v2_afaef5bfe4c9. ClinicalTrials.gov NCT00128856, versions 1-2. 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 the outcome change was inconsistent with the protocol or statistical analysis plan.","That event-class membership is a validated global review-priority ranking."],"claims_supported":["TrialDiff compared ClinicalTrials.gov record version 1 to version 2 for NCT00128856.","The JSON Patch for this comparison has hash 4e5eeb2a90212d5be4f8dfb2785c94cb688713bf9d917373d76c58cc368312ac.","The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.","The deterministic triage label was critical; before timing adjustment it was critical.","The triage label is uncalibrated metadata, not a validated review-priority finding.","The patch satisfied these deterministic event-class predicates: primary_endpoint_changed_after_primary_completion_without_results_reconciliation.","A registry field under the primary outcome module changed between ClinicalTrials.gov versions 1 and 2.","The timing context for the from-version record was post_recruitment.","The deterministic rules that fired were: arms_or_interventions_change, design_info_change, enrollment_count_change, primary_outcome_any_change, secondary_outcome_any_change.","The changed JSON Pointer paths were: /protocolSection/identificationModule/officialTitle, /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/startDateStruct/date, /protocolSection/statusModule/startDateStruct/type, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/completionDateStruct/type, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/lastUpdatePostDateStruct/type, /protocolSection/statusModule/primaryCompletionDateStruct, /protocolSection/sponsorCollaboratorsModule/responsibleParty, /protocolSection/designModule/designInfo/allocation, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/designModule/enrollmentInfo/type, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels, /protocolSection/armsInterventionsModule/interventions/0/otherNames, /protocolSection/armsInterventionsModule/interventions/1, /protocolSection/armsInterventionsModule/interventions/1, /protocolSection/armsInterventionsModule/armGroups, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/5/description, /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame, /protocolSection/contactsLocationsModule/overallOfficials/0/name, /protocolSection/contactsLocationsModule/overallOfficials/0/affiliation, /protocolSection/contactsLocationsModule/overallOfficials/0/role, /protocolSection/contactsLocationsModule/overallOfficials/1/name, /protocolSection/contactsLocationsModule/overallOfficials/1/affiliation, /protocolSection/contactsLocationsModule/overallOfficials/1/role, /protocolSection/contactsLocationsModule/locations/0/facility, /protocolSection/contactsLocationsModule/locations/0/city, /protocolSection/contactsLocationsModule/locations/0/state, /protocolSection/contactsLocationsModule/locations/0/zip, /protocolSection/contactsLocationsModule/locations/0/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/0/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/1, /protocolSection/contactsLocationsModule/locations/2, /protocolSection/contactsLocationsModule/locations/3, /protocolSection/contactsLocationsModule/locations/4, /protocolSection/contactsLocationsModule/locations/5, /protocolSection/contactsLocationsModule/locations/6, /protocolSection/contactsLocationsModule/locations/7, /protocolSection/contactsLocationsModule/locations/8, /protocolSection/contactsLocationsModule/locations/9.","The timeline value moved by 90 days.","The timeline value moved by 3440 days.","A timeline value changed and was classified by TrialDiff's timeline signal rules.","A primary outcome definition field changed after primary completion between versions 1 and 2, without a results-posting co-occurrence signal."],"classification":{"calibration_status":"uncalibrated","categories":["primary_outcome_change","design_change","arm_intervention_change","secondary_outcome_change","enrollment_change","timeline_major_slip","timeline_shift"],"category":"primary_outcome_change","deterministic_rules":["arms_or_interventions_change","design_info_change","enrollment_count_change","primary_outcome_any_change","secondary_outcome_any_change"],"event_class_rule_set_hash":"74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c","event_classes":["primary_endpoint_changed_after_primary_completion_without_results_reconciliation"],"rule_set_hash":"fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621","severity":"critical","severity_pre_timing":"critical","timing_context":"post_recruitment","triage_label":"critical","triage_rule_set_hash":"af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b","value_signals":[{"category":"timeline_shift","date_struct":"startDateStruct","delta_days":90,"direction":"later","new_precision":"month","new_type":"ACTUAL","new_value":"2003-03","old_precision":"month","old_type":null,"old_value":"2002-12","path":"/protocolSection/statusModule/startDateStruct/date","severity":"medium","signal":"timeline_shift"},{"category":"timeline_major_slip","date_struct":"completionDateStruct","delta_days":3440,"direction":"later","new_precision":"month","new_type":"ACTUAL","new_value":"2015-01","old_precision":"month","old_type":null,"old_value":"2005-08","path":"/protocolSection/statusModule/completionDateStruct/date","severity":"high","signal":"timeline_major_slip"},{"category":"timeline_shift","date_struct":"primaryCompletionDateStruct","direction":"unknown","new_type":"ACTUAL","new_value":"2015-01","old_type":null,"old_value":null,"path":"/protocolSection/statusModule/primaryCompletionDateStruct","reason":"date_unparsed_or_missing","severity":"medium","signal":"timeline_shift"}]},"event_id":"evt_NCT00128856_v1_v2_afaef5bfe4c9","evidence_version":1,"patch":[{"op":"replace","path":"/protocolSection/identificationModule/officialTitle","value":"Phase 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years"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/overallOfficials/0/name","value":"Study Director"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/overallOfficials/0/affiliation","value":"Hospital Miguel Servet"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/overallOfficials/0/role","value":"STUDY_DIRECTOR"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/overallOfficials/1/name","value":"Study Director"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/overallOfficials/1/affiliation","value":"Complejo Hospitalrio de Ja\u00e9n"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/overallOfficials/1/role","value":"STUDY_DIRECTOR"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/0/facility","value":"Hospital Universitario Germans Trias i 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