{"analyses":[{"ciLowerLimit":"0.433","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.756","estimateComment":"Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.","groupDescription":"The primary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\\> Veliparib group (Arm 3) vs. the Placebo + Carboplatin + Paclitaxel -\\> Placebo group (Arm 1).","groupIds":["OG000","OG002"],"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":"<0.001","pValueComment":"A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.","paramType":"Hazard Ratio (HR)","paramValue":"0.572","statisticalComment":"Stratified according to residual disease status and disease stage.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"17.8","upperLimit":"22.8","value":"20.5"},{"groupId":"OG001","lowerLimit":"16.4","upperLimit":"22.7","value":"18.1"},{"groupId":"OG002","lowerLimit":"25.8","upperLimit":"38.0","value":"31.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"206"},{"groupId":"OG002","value":"214"}],"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 if disease progression was not reached. If the participant did not have an event of disease progression 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. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached and was performed in 3 sequentially inclusive populations.\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\n.","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 second analysis was conducted using the HRD cohort which included participants in the BRCA-mutation cohort and those determined to have HRD tumors.","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 Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1)","type":"PRIMARY","unitOfMeasure":"months"}