{"changed_paths":["/protocolSection/identificationModule/briefTitle","/protocolSection/statusModule/statusVerifiedDate","/protocolSection/statusModule/overallStatus","/protocolSection/statusModule/primaryCompletionDateStruct/type","/protocolSection/statusModule/completionDateStruct/type","/protocolSection/statusModule/lastUpdateSubmitDate","/protocolSection/statusModule/lastUpdatePostDateStruct/date","/protocolSection/statusModule/resultsFirstSubmitDate","/protocolSection/statusModule/resultsFirstSubmitQcDate","/protocolSection/statusModule/resultsFirstPostDateStruct","/protocolSection/descriptionModule/briefSummary","/protocolSection/armsInterventionsModule/interventions/0/description","/protocolSection/outcomesModule/primaryOutcomes/0/measure","/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame","/protocolSection/outcomesModule/primaryOutcomes/0/description","/protocolSection/outcomesModule/secondaryOutcomes/0/measure","/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/0/description","/protocolSection/outcomesModule/secondaryOutcomes/1","/protocolSection/outcomesModule/secondaryOutcomes/2","/protocolSection/outcomesModule/secondaryOutcomes/3","/protocolSection/outcomesModule/secondaryOutcomes/4","/protocolSection/outcomesModule/secondaryOutcomes/5","/protocolSection/contactsLocationsModule/locations/25/state","/protocolSection/contactsLocationsModule/locations/31/state","/protocolSection/contactsLocationsModule/locations/39/state","/protocolSection/contactsLocationsModule/locations/41/state","/protocolSection/contactsLocationsModule/locations/42/state","/protocolSection/contactsLocationsModule/locations/43/state","/protocolSection/contactsLocationsModule/locations/52/state","/hasResults","/resultsSection"],"citation_text":"TrialDiff Evidence Record evt_NCT00099437_v15_v16_4fecfb6d151e. ClinicalTrials.gov NCT00099437, versions 15-16. 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 15 to version 16 for NCT00099437.","The JSON Patch for this comparison has hash 477e4641403c0dfc570730b72360e62aef2e82a632852e66626ce06ba1806443.","The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.","The deterministic triage label was high; before timing adjustment it was high.","The triage label is uncalibrated metadata, not a validated review-priority finding.","The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting.","A registry field under an arm or intervention module changed between ClinicalTrials.gov versions 15 and 16.","The timing context for the from-version record was late_recruitment.","The deterministic rules that fired were: arms_or_interventions_change.","The changed JSON Pointer paths were: /protocolSection/identificationModule/briefTitle, /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/overallStatus, /protocolSection/statusModule/primaryCompletionDateStruct/type, /protocolSection/statusModule/completionDateStruct/type, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, 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of Fulvestrant (FASLODEX\u2122) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy."},{"op":"replace","path":"/protocolSection/statusModule/statusVerifiedDate","value":"2010-05"},{"op":"replace","path":"/protocolSection/statusModule/overallStatus","value":"COMPLETED"},{"op":"replace","path":"/protocolSection/statusModule/primaryCompletionDateStruct/type","value":"ACTUAL"},{"op":"replace","path":"/protocolSection/statusModule/completionDateStruct/type","value":"ACTUAL"},{"op":"replace","path":"/protocolSection/statusModule/lastUpdateSubmitDate","value":"2010-05-12"},{"op":"replace","path":"/protocolSection/statusModule/lastUpdatePostDateStruct/date","value":"2010-06-15"},{"op":"add","path":"/protocolSection/statusModule/resultsFirstSubmitDate","value":"2010-02-23"},{"op":"add","path":"/protocolSection/statusModule/resultsFirstSubmitQcDate","value":"2010-05-12"},{"op":"add","path":"/protocolSection/statusModule/resultsFirstPostDateStruct","value":{"date":"2010-06-15","type":"ESTIMATED"}},{"op":"replace","path":"/protocolSection/descriptionModule/briefSummary","value":"The 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RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)"}},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/2","value":{"description":"Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)","measure":"Duration of Response (DoR)","timeFrame":"RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)"}},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/3","value":{"description":"Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks","measure":"Duration of Clinical Benefit (DoCB)","timeFrame":"RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)"}},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/4","value":{"description":"Median time (in months) from randomisation until death (from any cause)","measure":"Overall Survival (OS)","timeFrame":"Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)"}},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/5","value":{"description":"Median time (in months) from randomisation until deterioration in TOI (defined as the first visit response of 'worsened') using the Kaplan-Meier method.\nTrial Outcome Index (TOI) is derived from the FACT-B questionnaire.\nData were collected from a subgroup of patients.","measure":"Time to Deterioration in Trial Outcome Index (TOI)","timeFrame":"TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)"}},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/25/state","value":"S\ufffdo Paulo"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/31/state","value":"Praha 5"},{"op":"replace","path":"/protocolSection/contactsLocationsModule/locations/39/state","value":"Andh 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