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Kaplan-Meier methods, stratified by study group, and the log rank test will be completed.","reportingStatus":"NOT_POSTED","timeFrame":"Up to 3 years","title":"Relapse Free Survival","type":"SECONDARY"}]},"participantFlowModule":{"groups":[{"description":"<p>Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p>","id":"FG000","title":"Arm 1 (Paclitaxel, Carboplatin)"},{"description":"<p>Patients receive veliparib PO BID on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p><p>Veliparib: Given PO</p>","id":"FG001","title":"Arm 2 (Veliparib, Paclitaxel, Carboplatin)"}],"periods":[{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"4"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"4"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}]}}}],"provenance":{"from_snapshot_hash":"e7c2f5cfa87463e9014601f04d4fe591d3a3826c2ccadce96528761a80e0922d","materiality_event_hash":"7b79f53742fb70751a912a86cb571bc01b05016a8b80f42c8e060f4560e60c24","patch_hash":"3b34ee57f0bf5eb3ee1858404e8a7f98410235d62b218fd80457276481690f8f","patch_raw_hash":"997aceb9617118bbd9a4d64750d16df2e2cef981e3c4e6b968166ac8443a6c1f","patch_source":"ctgov_internal_history","patch_source_url":"https://clinicaltrials.gov/api/int/studies/NCT01818063/history/14?patchToVersion=15","to_snapshot_hash":"5533a5710a87296df798572e29262c3d74af0c24441d1907929efa0bf7a027af"},"review_question":"What source document explains this registry amendment, and does it change interpretation of the trial record?","schema":"trialdiff.evidence_record","trial":{"clinicaltrials_gov_url":"https://clinicaltrials.gov/study/NCT01818063","nct_id":"NCT01818063"},"versions":{"from_version":14,"submitted_date":"2017-12-14","to_version":15}}