{"analyses":[{"ciLowerLimit":"0.895","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.287","estimateComment":"Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.","groupDescription":"The secondary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\\> Placebo group (Arm 2) vs. the Placebo + Carboplatin + Paclitaxel -\\> Placebo group (Arm 1).","groupIds":["OG000","OG001"],"nonInferiorityComment":"Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.","nonInferiorityType":"SUPERIORITY","pValue":"0.450","paramType":"Hazard Ratio (HR)","paramValue":"1.073","statisticalComment":"Stratified according to residual disease status and disease stage, choice of the paclitaxel regimen, and BRCA-mutation status","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.1","upperLimit":"19.1","value":"17.3"},{"groupId":"OG001","lowerLimit":"14.1","upperLimit":"17.3","value":"15.2"},{"groupId":"OG002","lowerLimit":"19.3","upperLimit":"26.3","value":"23.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"375"},{"groupId":"OG001","value":"383"},{"groupId":"OG002","value":"382"}],"units":"Participants"}],"description":"PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death (all causes of mortality) if disease progression was not reached. If the participant did not have an event of disease progression according to RECIST criteria (as or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method.\n\nProgressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions.\n\nThe primary analysis of PFS occurred when the protocol-specified number of PFS events was reached.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \\[AUC\\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.\n\nParticipants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.","id":"OG000","title":"Placebo + Carboplatin + Paclitaxel -> Placebo"},{"description":"Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.\n\nParticipants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.","id":"OG001","title":"Veliparib + Carboplatin + Paclitaxel -> Placebo"},{"description":"Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.\n\nParticipants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.","id":"OG002","title":"Veliparib + Carboplatin + Paclitaxel -> Veliparib"}],"paramType":"MEDIAN","populationDescription":"Analyses were performed in 3 sequentially inclusive populations. The third analysis was conducted using the intention-to-treat (ITT) population (all randomized participants).","reportingStatus":"POSTED","timeFrame":"From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.","title":"Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 2 vs Arm 1)","type":"SECONDARY","unitOfMeasure":"months"}