{"changed_paths":["/protocolSection/statusModule/statusVerifiedDate","/protocolSection/statusModule/completionDateStruct/date","/protocolSection/statusModule/lastUpdateSubmitDate","/protocolSection/statusModule/lastUpdatePostDateStruct/date","/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/4/description","/protocolSection/outcomesModule/secondaryOutcomes/5/measure","/protocolSection/outcomesModule/secondaryOutcomes/5/description","/protocolSection/outcomesModule/secondaryOutcomes/6","/protocolSection/eligibilityModule/stdAges/0","/protocolSection/eligibilityModule/minimumAge","/protocolSection/contactsLocationsModule/locations/0","/protocolSection/contactsLocationsModule/locations/0","/protocolSection/contactsLocationsModule/locations/2","/protocolSection/contactsLocationsModule/locations/8","/protocolSection/contactsLocationsModule/locations/11/state","/protocolSection/contactsLocationsModule/locations/12/city","/protocolSection/contactsLocationsModule/locations/12/state","/protocolSection/contactsLocationsModule/locations/13/city","/protocolSection/contactsLocationsModule/locations/13/state","/protocolSection/contactsLocationsModule/locations/14/state","/protocolSection/contactsLocationsModule/locations/15/state","/protocolSection/contactsLocationsModule/locations/16/state","/protocolSection/contactsLocationsModule/locations/17/state","/protocolSection/contactsLocationsModule/locations/18/state","/protocolSection/contactsLocationsModule/locations/19/state","/protocolSection/contactsLocationsModule/locations/20/city","/protocolSection/contactsLocationsModule/locations/20/state","/protocolSection/contactsLocationsModule/locations/20/geoPoint/lat","/protocolSection/contactsLocationsModule/locations/20/geoPoint/lon","/protocolSection/contactsLocationsModule/locations/21/city","/protocolSection/contactsLocationsModule/locations/21/state","/protocolSection/contactsLocationsModule/locations/21/geoPoint/lat","/protocolSection/contactsLocationsModule/locations/21/geoPoint/lon","/protocolSection/contactsLocationsModule/locations/22/city","/protocolSection/contactsLocationsModule/locations/22/state","/protocolSection/contactsLocationsModule/locations/22/geoPoint/lat","/protocolSection/contactsLocationsModule/locations/22/geoPoint/lon","/protocolSection/contactsLocationsModule/locations/23/city","/protocolSection/contactsLocationsModule/locations/23/state","/protocolSection/contactsLocationsModule/locations/23/country","/protocolSection/contactsLocationsModule/locations/23/geoPoint/lat","/protocolSection/contactsLocationsModule/locations/23/geoPoint/lon","/protocolSection/contactsLocationsModule/locations/24/city","/protocolSection/contactsLocationsModule/locations/24/country","/protocolSection/contactsLocationsModule/locations/24/geoPoint/lat","/protocolSection/contactsLocationsModule/locations/24/geoPoint/lon","/protocolSection/contactsLocationsModule/locations/25/city","/protocolSection/contactsLocationsModule/locations/25/country","/protocolSection/contactsLocationsModule/locations/25/geoPoint/lat","/protocolSection/contactsLocationsModule/locations/25/geoPoint/lon","/protocolSection/contactsLocationsModule/locations/26","/protocolSection/contactsLocationsModule/locations/26","/protocolSection/contactsLocationsModule/locations/26","/protocolSection/contactsLocationsModule/locations/31/city","/protocolSection/contactsLocationsModule/locations/31/country","/protocolSection/contactsLocationsModule/locations/31/geoPoint","/protocolSection/contactsLocationsModule/locations/32","/protocolSection/contactsLocationsModule/locations/33/state","/protocolSection/contactsLocationsModule/locations/34/city","/protocolSection/contactsLocationsModule/locations/34/state","/protocolSection/contactsLocationsModule/locations/34/geoPoint/lat","/protocolSection/contactsLocationsModule/locations/34/geoPoint/lon","/protocolSection/contactsLocationsModule/locations/35/city","/protocolSection/contactsLocationsModule/locations/35/state","/protocolSection/contactsLocationsModule/locations/35/geoPoint/lat","/protocolSection/contactsLocationsModule/locations/35/geoPoint/lon","/protocolSection/contactsLocationsModule/locations/36/city","/protocolSection/contactsLocationsModule/locations/36/state","/protocolSection/contactsLocationsModule/locations/36/geoPoint","/protocolSection/contactsLocationsModule/locations/37/state","/protocolSection/contactsLocationsModule/locations/38","/protocolSection/contactsLocationsModule/locations/38","/protocolSection/contactsLocationsModule/locations/38","/protocolSection/contactsLocationsModule/locations/38","/protocolSection/contactsLocationsModule/locations/38","/protocolSection/contactsLocationsModule/locations/39/city","/protocolSection/contactsLocationsModule/locations/39/state","/protocolSection/contactsLocationsModule/locations/39/country","/protocolSection/contactsLocationsModule/locations/39/geoPoint/lat","/protocolSection/contactsLocationsModule/locations/39/geoPoint/lon","/protocolSection/contactsLocationsModule/locations/40/city","/protocolSection/contactsLocationsModule/locations/40/state","/protocolSection/contactsLocationsModule/locations/40/geoPoint/lat","/protocolSection/contactsLocationsModule/locations/40/geoPoint/lon","/protocolSection/contactsLocationsModule/locations/41/city","/protocolSection/contactsLocationsModule/locations/41/state","/protocolSection/contactsLocationsModule/locations/41/geoPoint/lat","/protocolSection/contactsLocationsModule/locations/41/geoPoint/lon","/protocolSection/contactsLocationsModule/locations/42/city","/protocolSection/contactsLocationsModule/locations/42/state","/protocolSection/contactsLocationsModule/locations/42/geoPoint/lat","/protocolSection/contactsLocationsModule/locations/42/geoPoint/lon","/protocolSection/contactsLocationsModule/locations/43/state","/protocolSection/contactsLocationsModule/locations/44/state","/protocolSection/contactsLocationsModule/locations/45/state","/protocolSection/contactsLocationsModule/locations/47","/protocolSection/contactsLocationsModule/locations/48","/protocolSection/contactsLocationsModule/locations/52","/protocolSection/contactsLocationsModule/locations/52","/protocolSection/contactsLocationsModule/locations/57","/protocolSection/contactsLocationsModule/locations/60","/protocolSection/contactsLocationsModule/locations/62/city","/protocolSection/contactsLocationsModule/locations/62/country","/protocolSection/contactsLocationsModule/locations/62/geoPoint/lat","/protocolSection/contactsLocationsModule/locations/62/geoPoint/lon","/protocolSection/contactsLocationsModule/locations/63/state","/protocolSection/contactsLocationsModule/locations/64/city","/protocolSection/contactsLocationsModule/locations/64/state","/protocolSection/contactsLocationsModule/locations/64/geoPoint/lat","/protocolSection/contactsLocationsModule/locations/64/geoPoint/lon","/protocolSection/contactsLocationsModule/locations/65/state","/protocolSection/contactsLocationsModule/locations/65/geoPoint/lat","/protocolSection/contactsLocationsModule/locations/65/geoPoint/lon","/protocolSection/contactsLocationsModule/locations/66/city","/protocolSection/contactsLocationsModule/locations/66/state","/protocolSection/contactsLocationsModule/locations/66/geoPoint","/protocolSection/contactsLocationsModule/locations/67","/protocolSection/contactsLocationsModule/locations/67","/protocolSection/contactsLocationsModule/locations/73","/protocolSection/contactsLocationsModule/locations/74","/protocolSection/referencesModule/seeAlsoLinks","/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/0/comment","/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/0/numSubjects","/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/1/comment","/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/1/numSubjects","/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/0/numSubjects","/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/1/numSubjects","/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/type","/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/0/numSubjects","/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/1/numSubjects","/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/type","/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/0/numSubjects","/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/1/numSubjects","/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/type","/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/0/numSubjects","/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/1/numSubjects","/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/type","/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/0/numSubjects","/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/1/numSubjects","/resultsSection/participantFlowModule/periods/0/dropWithdraws/4","/resultsSection/participantFlowModule/periods/0/dropWithdraws/4","/resultsSection/participantFlowModule/periods/0/dropWithdraws/4","/resultsSection/participantFlowModule/periods/0/dropWithdraws/4","/resultsSection/baselineCharacteristicsModule/measures/0/title","/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame","/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/0/upperLimit","/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/0/comment","/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/1/upperLimit","/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/1/comment","/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/upperLimit","/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/comment","/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/upperLimit","/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/comment","/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/0/upperLimit","/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/0/comment","/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/upperLimit","/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/comment","/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description","/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/upperLimit","/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/comment","/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/upperLimit","/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/comment","/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/title","/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/description","/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/reportingStatus","/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/paramType","/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/dispersionType","/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/unitOfMeasure","/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups","/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms","/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes","/resultsSection/outcomeMeasuresModule/outcomeMeasures/7","/resultsSection/adverseEventsModule/description","/resultsSection/adverseEventsModule/eventGroups/0/seriousNumAffected","/resultsSection/adverseEventsModule/eventGroups/1/seriousNumAffected","/resultsSection/adverseEventsModule/seriousEvents/0/stats/1/numAffected","/resultsSection/adverseEventsModule/seriousEvents/5/stats/0/numAffected","/resultsSection/adverseEventsModule/seriousEvents/20/stats/1/numAffected","/resultsSection/adverseEventsModule/seriousEvents/26/stats/0/numAffected","/resultsSection/adverseEventsModule/seriousEvents/31/stats/1/numAffected","/resultsSection/adverseEventsModule/seriousEvents/61","/resultsSection/adverseEventsModule/seriousEvents/62","/resultsSection/adverseEventsModule/seriousEvents/63","/resultsSection/adverseEventsModule/seriousEvents/64","/resultsSection/adverseEventsModule/seriousEvents/65","/resultsSection/adverseEventsModule/seriousEvents/66","/resultsSection/adverseEventsModule/timeFrame"],"citation_text":"TrialDiff Evidence Record evt_NCT00099437_v22_v23_2fe77a937f58. ClinicalTrials.gov NCT00099437, versions 22-23. 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 22 to version 23 for NCT00099437.","The JSON Patch for this comparison has hash f024c4431266fe5000b3bf7c84929367a32ba4f22bd7e219a301e56cbce4597a.","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 path under serious adverse event results was added between ClinicalTrials.gov versions 22 and 23.","The timing context for the from-version record was late_recruitment.","The deterministic rules that fired were: adverse_event_group_change, 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/4/description, /protocolSection/outcomesModule/secondaryOutcomes/5/measure, /protocolSection/outcomesModule/secondaryOutcomes/5/description, /protocolSection/outcomesModule/secondaryOutcomes/6, /protocolSection/eligibilityModule/stdAges/0, /protocolSection/eligibilityModule/minimumAge, /protocolSection/contactsLocationsModule/locations/0, /protocolSection/contactsLocationsModule/locations/0, /protocolSection/contactsLocationsModule/locations/2, /protocolSection/contactsLocationsModule/locations/8, /protocolSection/contactsLocationsModule/locations/11/state, /protocolSection/contactsLocationsModule/locations/12/city, /protocolSection/contactsLocationsModule/locations/12/state, /protocolSection/contactsLocationsModule/locations/13/city, /protocolSection/contactsLocationsModule/locations/13/state, /protocolSection/contactsLocationsModule/locations/14/state, /protocolSection/contactsLocationsModule/locations/15/state, /protocolSection/contactsLocationsModule/locations/16/state, /protocolSection/contactsLocationsModule/locations/17/state, /protocolSection/contactsLocationsModule/locations/18/state, /protocolSection/contactsLocationsModule/locations/19/state, /protocolSection/contactsLocationsModule/locations/20/city, /protocolSection/contactsLocationsModule/locations/20/state, /protocolSection/contactsLocationsModule/locations/20/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/20/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/21/city, /protocolSection/contactsLocationsModule/locations/21/state, /protocolSection/contactsLocationsModule/locations/21/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/21/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/22/city, /protocolSection/contactsLocationsModule/locations/22/state, /protocolSection/contactsLocationsModule/locations/22/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/22/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/23/city, /protocolSection/contactsLocationsModule/locations/23/state, /protocolSection/contactsLocationsModule/locations/23/country, /protocolSection/contactsLocationsModule/locations/23/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/23/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/24/city, /protocolSection/contactsLocationsModule/locations/24/country, /protocolSection/contactsLocationsModule/locations/24/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/24/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/25/city, /protocolSection/contactsLocationsModule/locations/25/country, /protocolSection/contactsLocationsModule/locations/25/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/25/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/26, /protocolSection/contactsLocationsModule/locations/26, /protocolSection/contactsLocationsModule/locations/26, /protocolSection/contactsLocationsModule/locations/31/city, /protocolSection/contactsLocationsModule/locations/31/country, /protocolSection/contactsLocationsModule/locations/31/geoPoint, /protocolSection/contactsLocationsModule/locations/32, /protocolSection/contactsLocationsModule/locations/33/state, /protocolSection/contactsLocationsModule/locations/34/city, /protocolSection/contactsLocationsModule/locations/34/state, /protocolSection/contactsLocationsModule/locations/34/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/34/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/35/city, /protocolSection/contactsLocationsModule/locations/35/state, /protocolSection/contactsLocationsModule/locations/35/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/35/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/36/city, /protocolSection/contactsLocationsModule/locations/36/state, /protocolSection/contactsLocationsModule/locations/36/geoPoint, /protocolSection/contactsLocationsModule/locations/37/state, /protocolSection/contactsLocationsModule/locations/38, /protocolSection/contactsLocationsModule/locations/38, /protocolSection/contactsLocationsModule/locations/38, /protocolSection/contactsLocationsModule/locations/38, /protocolSection/contactsLocationsModule/locations/38, /protocolSection/contactsLocationsModule/locations/39/city, /protocolSection/contactsLocationsModule/locations/39/state, /protocolSection/contactsLocationsModule/locations/39/country, /protocolSection/contactsLocationsModule/locations/39/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/39/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/40/city, /protocolSection/contactsLocationsModule/locations/40/state, /protocolSection/contactsLocationsModule/locations/40/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/40/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/41/city, /protocolSection/contactsLocationsModule/locations/41/state, /protocolSection/contactsLocationsModule/locations/41/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/41/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/42/city, /protocolSection/contactsLocationsModule/locations/42/state, /protocolSection/contactsLocationsModule/locations/42/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/42/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/43/state, /protocolSection/contactsLocationsModule/locations/44/state, /protocolSection/contactsLocationsModule/locations/45/state, /protocolSection/contactsLocationsModule/locations/47, /protocolSection/contactsLocationsModule/locations/48, /protocolSection/contactsLocationsModule/locations/52, /protocolSection/contactsLocationsModule/locations/52, /protocolSection/contactsLocationsModule/locations/57, /protocolSection/contactsLocationsModule/locations/60, /protocolSection/contactsLocationsModule/locations/62/city, /protocolSection/contactsLocationsModule/locations/62/country, /protocolSection/contactsLocationsModule/locations/62/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/62/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/63/state, /protocolSection/contactsLocationsModule/locations/64/city, /protocolSection/contactsLocationsModule/locations/64/state, /protocolSection/contactsLocationsModule/locations/64/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/64/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/65/state, /protocolSection/contactsLocationsModule/locations/65/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/65/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/66/city, /protocolSection/contactsLocationsModule/locations/66/state, /protocolSection/contactsLocationsModule/locations/66/geoPoint, /protocolSection/contactsLocationsModule/locations/67, /protocolSection/contactsLocationsModule/locations/67, /protocolSection/contactsLocationsModule/locations/73, /protocolSection/contactsLocationsModule/locations/74, /protocolSection/referencesModule/seeAlsoLinks, /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/0/comment, /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/0/numSubjects, /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/1/comment, /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/1/numSubjects, /resultsSection/participantFlowModule/periods/0/milestones/2/achievements/0/numSubjects, /resultsSection/participantFlowModule/periods/0/milestones/2/achievements/1/numSubjects, /resultsSection/participantFlowModule/periods/0/dropWithdraws/0/type, /resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/0/numSubjects, /resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/1/numSubjects, /resultsSection/participantFlowModule/periods/0/dropWithdraws/1/type, /resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/0/numSubjects, /resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/1/numSubjects, /resultsSection/participantFlowModule/periods/0/dropWithdraws/2/type, /resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/0/numSubjects, /resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/1/numSubjects, /resultsSection/participantFlowModule/periods/0/dropWithdraws/3/type, /resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/0/numSubjects, /resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/1/numSubjects, /resultsSection/participantFlowModule/periods/0/dropWithdraws/4, /resultsSection/participantFlowModule/periods/0/dropWithdraws/4, /resultsSection/participantFlowModule/periods/0/dropWithdraws/4, /resultsSection/participantFlowModule/periods/0/dropWithdraws/4, /resultsSection/baselineCharacteristicsModule/measures/0/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/0/upperLimit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/0/comment, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/1/upperLimit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/1/comment, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/upperLimit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/comment, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/upperLimit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/comment, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/0/upperLimit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/0/comment, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/upperLimit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/comment, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/upperLimit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/comment, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/upperLimit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/comment, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/paramType, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/dispersionType, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/unitOfMeasure, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7, /resultsSection/adverseEventsModule/description, /resultsSection/adverseEventsModule/eventGroups/0/seriousNumAffected, /resultsSection/adverseEventsModule/eventGroups/1/seriousNumAffected, /resultsSection/adverseEventsModule/seriousEvents/0/stats/1/numAffected, /resultsSection/adverseEventsModule/seriousEvents/5/stats/0/numAffected, /resultsSection/adverseEventsModule/seriousEvents/20/stats/1/numAffected, /resultsSection/adverseEventsModule/seriousEvents/26/stats/0/numAffected, /resultsSection/adverseEventsModule/seriousEvents/31/stats/1/numAffected, /resultsSection/adverseEventsModule/seriousEvents/61, /resultsSection/adverseEventsModule/seriousEvents/62, /resultsSection/adverseEventsModule/seriousEvents/63, /resultsSection/adverseEventsModule/seriousEvents/64, /resultsSection/adverseEventsModule/seriousEvents/65, /resultsSection/adverseEventsModule/seriousEvents/66, /resultsSection/adverseEventsModule/timeFrame.","The timeline value moved by 487 days.","An outcome path changed between versions 22 and 23 in a patch that also carried a hasResults or resultsSection co-occurrence signal."],"classification":{"calibration_status":"uncalibrated","categories":["serious_adverse_event_addition","serious_adverse_event_modification","adverse_event_group_change","timeline_major_slip","results_reconciliation"],"category":"serious_adverse_event_addition","deterministic_rules":["adverse_event_group_change","serious_adverse_event_addition","serious_adverse_event_modification"],"event_class_rule_set_hash":"74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c","event_classes":["outcome_edit_cooccurs_with_results_posting"],"rule_set_hash":"fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621","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":487,"direction":"later","new_precision":"month","new_type":"ESTIMATED","new_value":"2015-01","old_precision":"month","old_type":"ESTIMATED","old_value":"2013-09","path":"/protocolSection/statusModule/completionDateStruct/date","severity":"high","signal":"timeline_major_slip"},{"category":"results_reconciliation","paths":["/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/4/description","/protocolSection/outcomesModule/secondaryOutcomes/5/description","/protocolSection/outcomesModule/secondaryOutcomes/5/measure","/protocolSection/outcomesModule/secondaryOutcomes/6"],"severity":"low","signal":"results_reconciliation_outcome_suppression"}]},"event_id":"evt_NCT00099437_v22_v23_2fe77a937f58","evidence_version":1,"patch":[{"op":"replace","path":"/protocolSection/statusModule/statusVerifiedDate","value":"2014-08"},{"op":"replace","path":"/protocolSection/statusModule/completionDateStruct/date","value":"2015-01"},{"op":"replace","path":"/protocolSection/statusModule/lastUpdateSubmitDate","value":"2014-08-29"},{"op":"replace","path":"/protocolSection/statusModule/lastUpdatePostDateStruct/date","value":"2014-09-01"},{"op":"replace","path":"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame","value":"RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/4/description","value":"Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/5/measure","value":"Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/5/description","value":"Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method.\nIf a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date.\nTrial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS).\nThe TOI score range is 0-92 with the higher scores representing the more favourable outcomes.\nData were collected from a subgroup of patients."},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/6","value":{"description":"Overall Survival is equivalent to time to death.\nFor this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths)","measure":"Overall Survival (OS) - Follow-up","timeFrame":"Median time (in months) from randomisation until death (from any cause),up to 80 months"}},{"op":"remove","path":"/protocolSection/eligibilityModule/stdAges/0"},{"op":"add","path":"/protocolSection/eligibilityModule/minimumAge","value":"45 Years"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/0"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/0"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/2"},{"op":"add","path":"/protocolSection/contactsLocationsModule/locations/8","value":{"city":"Greenville","country":"United States","facility":"Research Site","geoPoint":{"lat":35.61266,"lon":-77.36635},"state":"North Carolina"}},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/11/state"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/12/city","value":"Brussels (Anderlecht)"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/12/state"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/13/city","value":"Brussels (Jette)"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/13/state"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/14/state"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/15/state"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/16/state"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/17/state"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/18/state"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/19/state"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/20/city","value":"Porto Alegre"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/20/state"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/20/geoPoint/lat","value":-30.03283},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/20/geoPoint/lon","value":-51.23019},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/21/city","value":"Recife"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/21/state"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/21/geoPoint/lat","value":-8.05389},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/21/geoPoint/lon","value":-34.88111},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/22/city","value":"S\u00e3o Paulo"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/22/state"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/22/geoPoint/lat","value":-23.5475},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/22/geoPoint/lon","value":-46.63611},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/23/city","value":"Santiago"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/23/state"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/23/country","value":"Chile"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/23/geoPoint/lat","value":-33.45694},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/23/geoPoint/lon","value":-70.64827},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/24/city","value":"Bogot\u00e1"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/24/country","value":"Colombia"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/24/geoPoint/lat","value":4.60971},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/24/geoPoint/lon","value":-74.08175},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/25/city","value":"Cali"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/25/country","value":"Colombia"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/25/geoPoint/lat","value":3.43054},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/25/geoPoint/lon","value":-76.5199},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/26"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/26"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/26"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/31/city","value":"V Uvalu 84"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/31/country","value":"Czechia"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/31/geoPoint"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/32"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/33/state"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/34/city","value":"Jaipur"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/34/state"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/34/geoPoint/lat","value":26.91962},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/34/geoPoint/lon","value":75.78781},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/35/city","value":"Kolkata"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/35/state"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/35/geoPoint/lat","value":22.56263},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/35/geoPoint/lon","value":88.36304},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/36/city","value":"Marg Jaipur"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/36/state"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/36/geoPoint"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/37/state"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/38"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/38"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/38"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/38"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/38"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/39/city","value":"Vellore"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/39/state"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/39/country","value":"India"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/39/geoPoint/lat","value":12.9184},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/39/geoPoint/lon","value":79.13255},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/40/city","value":"Aviano"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/40/state"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/40/geoPoint/lat","value":46.07056},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/40/geoPoint/lon","value":12.59472},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/41/city","value":"Bergamo"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/41/state"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/41/geoPoint/lat","value":45.69601},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/41/geoPoint/lon","value":9.66721},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/42/city","value":"Carpi"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/42/state"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/42/geoPoint/lat","value":44.78237},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/42/geoPoint/lon","value":10.8777},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/43/state"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/44/state"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/45/state"},{"op":"add","path":"/protocolSection/contactsLocationsModule/locations/47","value":{"city":"Mexico City","country":"Mexico","facility":"Research Site","geoPoint":{"lat":19.42847,"lon":-99.12766}}},{"op":"add","path":"/protocolSection/contactsLocationsModule/locations/48","value":{"city":"M\u00e9xico","country":"Mexico","facility":"Research Site","geoPoint":{"lat":31.00435,"lon":-108.15213}}},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/52"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/52"},{"op":"add","path":"/protocolSection/contactsLocationsModule/locations/57","value":{"city":"Obninsk","country":"Russia","facility":"Research Site","geoPoint":{"lat":55.10993,"lon":36.61238}}},{"op":"add","path":"/protocolSection/contactsLocationsModule/locations/60","value":{"city":"Yaroslavl","country":"Russia","facility":"Research Site","geoPoint":{"lat":57.62987,"lon":39.87368}}},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/62/city","value":"Madrid"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/62/country","value":"Spain"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/62/geoPoint/lat","value":40.4165},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/62/geoPoint/lon","value":-3.70256},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/63/state"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/64/city","value":"Oviedo"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/64/state"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/64/geoPoint/lat","value":43.36029},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/64/geoPoint/lon","value":-5.84476},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/65/state"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/65/geoPoint/lat","value":40.42972},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/65/geoPoint/lon","value":-3.67975},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/66/city","value":"Seville"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/66/state"},{"op":"add","path":"/protocolSection/contactsLocationsModule/locations/66/geoPoint","value":{"lat":37.38283,"lon":-5.97317}},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/67"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/67"},{"op":"remove","path":"/protocolSection/contactsLocationsModule/locations/73"},{"op":"add","path":"/protocolSection/contactsLocationsModule/locations/74","value":{"city":"Caracas","country":"Venezuela","facility":"Research Site","geoPoint":{"lat":10.48801,"lon":-66.87919}}},{"op":"add","path":"/protocolSection/referencesModule/seeAlsoLinks","value":[{"label":"CSP-D6997C00002.PDF","url":"http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=589&filename=CSP-D6997C00002.PDF"},{"label":"D6997C00002 Study Report Synopsis","url":"http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=589&filename=CSR-D6997C00002.pdf"}]},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/0/comment","value":"ongoing study treatment at survival follow-up data cut-off"},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/0/numSubjects","value":"8"},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/1/comment","value":"ongoing study treatment at survival follow-up data cut-off"},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/1/numSubjects","value":"13"},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/0/numSubjects","value":"366"},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/1/numSubjects","value":"349"},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/type","value":"Lost to Follow-up"},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/0/numSubjects","value":"30"},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/1/numSubjects","value":"33"},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/type","value":"Death"},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/0/numSubjects","value":"293"},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/1/numSubjects","value":"261"},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/type","value":"Withdrawal by Subject"},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/0/numSubjects","value":"6"},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/1/numSubjects","value":"10"},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/type","value":"Ongoing in FU but not on treatment"},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/0/numSubjects","value":"37"},{"op":"replace","path":"/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/1/numSubjects","value":"45"},{"op":"remove","path":"/resultsSection/participantFlowModule/periods/0/dropWithdraws/4"},{"op":"remove","path":"/resultsSection/participantFlowModule/periods/0/dropWithdraws/4"},{"op":"remove","path":"/resultsSection/participantFlowModule/periods/0/dropWithdraws/4"},{"op":"remove","path":"/resultsSection/participantFlowModule/periods/0/dropWithdraws/4"},{"op":"replace","path":"/resultsSection/baselineCharacteristicsModule/measures/0/title","value":"Age, Continuous"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame","value":"RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/0/upperLimit","value":"NA"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/0/comment","value":"Not Applicable - not all participants had an event at time of analysis, max time censored"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/1/upperLimit","value":"NA"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/1/comment","value":"Not Applicable - not all participants had an event at time of analysis, max time censored"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/upperLimit","value":"NA"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/comment","value":"Not Applicable - not all participants had an event at time of analysis, max time censored"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/upperLimit","value":"NA"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/comment","value":"Not Applicable - not all participants had an event at time of analysis, max time censored"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/0/upperLimit","value":"NA"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/0/comment","value":"Not Applicable - not all participants had an event at time of analysis, max time censored"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/upperLimit","value":"NA"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/comment","value":"Not Applicable - not all participants had an event at time of analysis, max time censored"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description","value":"Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/upperLimit","value":"NA"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/comment","value":"Not Applicable - not all participants had an event at time of analysis, max time censored"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/upperLimit","value":"NA"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/comment","value":"Not Applicable - not all participants had an event at time of analysis, max time censored"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/title","value":"Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/description","value":"Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method.\nIf a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date.\nTrial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS).\nThe TOI score range is 0-92 with the higher scores representing the more favourable outcomes.\nData were collected from a subgroup of patients."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/reportingStatus","value":"POSTED"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/paramType","value":"MEAN"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/dispersionType","value":"Standard Deviation"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/unitOfMeasure","value":"Scores on a scale"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups","value":[{"description":"Fulvestrant 250 mg Intramuscular Injection every 28 days","id":"OG000","title":"Fulvestrant 250 mg"},{"description":"Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14","id":"OG001","title":"Fulvestrant 500 mg"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms","value":[{"counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"34"}],"units":"Participants"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes","value":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.89","value":"-5.9"},{"groupId":"OG001","spread":"13.72","value":"-7.5"}]}]}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/7","value":{"classes":[{"categories":[{"measurements":[{"comment":"Not Applicable - not all participants had an event at time of analysis, max time censored","groupId":"OG000","lowerLimit":"0.2","upperLimit":"NA","value":"22.3"},{"comment":"Not Applicable - not all participants had an event at time of analysis, max time censored","groupId":"OG001","lowerLimit":"0.1","upperLimit":"NA","value":"26.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"374"},{"groupId":"OG001","value":"362"}],"units":"Participants"}],"description":"Overall Survival is equivalent to time to death.\nFor this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths)","dispersionType":"Full Range","groups":[{"description":"Fulvestrant 250 mg Intramuscular Injection every 28 days","id":"OG000","title":"Fulvestrant 250 mg"},{"description":"Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14","id":"OG001","title":"Fulvestrant 500 mg"}],"paramType":"MEDIAN","populationDescription":"All randomised patients","reportingStatus":"POSTED","timeFrame":"Median time (in months) from randomisation until death (from any cause),up to 80 months","title":"Overall Survival (OS) - Follow-up","type":"SECONDARY","unitOfMeasure":"months"}},{"op":"replace","path":"/resultsSection/adverseEventsModule/description","value":"1 participant was randomised to fulvestrant 500 mg but did not receive any treatment.\nAEs have been collected up to primary data cut off.\nSAEs have been collected up to follow-up phase data cut-off."},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/0/seriousNumAffected","value":27},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/1/seriousNumAffected","value":35},{"op":"replace","path":"/resultsSection/adverseEventsModule/seriousEvents/0/stats/1/numAffected","value":3},{"op":"replace","path":"/resultsSection/adverseEventsModule/seriousEvents/5/stats/0/numAffected","value":2},{"op":"replace","path":"/resultsSection/adverseEventsModule/seriousEvents/20/stats/1/numAffected","value":2},{"op":"replace","path":"/resultsSection/adverseEventsModule/seriousEvents/26/stats/0/numAffected","value":2},{"op":"replace","path":"/resultsSection/adverseEventsModule/seriousEvents/31/stats/1/numAffected","value":2},{"op":"add","path":"/resultsSection/adverseEventsModule/seriousEvents/61","value":{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 11.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":374},{"groupId":"EG001","numAffected":1,"numAtRisk":361}],"term":"ATRIAL FIBRILLATION"}},{"op":"add","path":"/resultsSection/adverseEventsModule/seriousEvents/62","value":{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 11.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":374},{"groupId":"EG001","numAffected":1,"numAtRisk":361}],"term":"ASTHENIA"}},{"op":"add","path":"/resultsSection/adverseEventsModule/seriousEvents/63","value":{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 11.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":374},{"groupId":"EG001","numAffected":1,"numAtRisk":361}],"term":"INFECTIOUS PERITONITIS"}},{"op":"add","path":"/resultsSection/adverseEventsModule/seriousEvents/64","value":{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 11.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":374},{"groupId":"EG001","numAffected":0,"numAtRisk":361}],"term":"FALL"}},{"op":"add","path":"/resultsSection/adverseEventsModule/seriousEvents/65","value":{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 11.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":374},{"groupId":"EG001","numAffected":1,"numAtRisk":361}],"term":"BONE PAIN"}},{"op":"add","path":"/resultsSection/adverseEventsModule/seriousEvents/66","value":{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 11.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":374},{"groupId":"EG001","numAffected":1,"numAtRisk":361}],"term":"HAEMOTHORAX"}},{"op":"add","path":"/resultsSection/adverseEventsModule/timeFrame","value":"SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009"}],"provenance":{"from_snapshot_hash":"7b90da67e5beeab036274b6e1986b52bb0809e408b283f82672061b065ae2327","materiality_event_hash":"710d14ee440e10110753e9585f508d16bec10bd835468835fbb5de0378937d99","patch_hash":"f024c4431266fe5000b3bf7c84929367a32ba4f22bd7e219a301e56cbce4597a","patch_raw_hash":"3acc98e2d127f63efaf7cce50f8f324649047e0341d30655bb7776609b827585","patch_source":"ctgov_internal_history","patch_source_url":"https://clinicaltrials.gov/api/int/studies/NCT00099437/history/22?patchToVersion=23","to_snapshot_hash":"902ef113a49f109f23523f53da382e62713d27ec9831e1dbbb9b59544ccb04cf"},"review_question":"What source document explains the added serious adverse event results record?","schema":"trialdiff.evidence_record","trial":{"clinicaltrials_gov_url":"https://clinicaltrials.gov/study/NCT00099437","nct_id":"NCT00099437"},"versions":{"from_version":22,"submitted_date":"2014-08-29","to_version":23}}