{"analyses":[{"ciLowerLimit":"0.640","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.114","estimateComment":"Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.","groupDescription":"Veliparib + Carboplatin + Paclitaxel -\\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\\> Placebo (Arm 1)","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.116","pValueComment":"Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)","paramType":"Hazard Ratio (HR)","paramValue":"0.844","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.726","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.242","estimateComment":"Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.","groupDescription":"Veliparib + Carboplatin + Paclitaxel -\\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\\> Placebo (Arm 1)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.352","pValueComment":"Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)","paramType":"Hazard Ratio (HR)","paramValue":"0.949","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"59.6","upperLimit":"87.6","value":"71.5"},{"comment":"Could not be estimated due to the low number of events","groupId":"OG001","lowerLimit":"65.4","upperLimit":"NA","value":"74.4"},{"comment":"Could not be estimated due to the low number of events","groupId":"OG002","lowerLimit":"73.8","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"206"},{"groupId":"OG002","value":"214"}],"units":"Participants"}],"description":"OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive.","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":"All randomized participants considered BRCA-Deficient and those determined to have HRD tumors based on HRD score","reportingStatus":"POSTED","timeFrame":"From the time of randomization to the end of the study, up to 98 months","title":"Overall Survival (OS) in the Homologous Recombination Deficiency Population","type":"SECONDARY","unitOfMeasure":"months"}