{"analyses":[{"ciLowerLimit":"0.328","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.610","estimateComment":"Hazard ratio was based on Cox proportional hazards model; under proportional hazards, hazard ratio \\< 1 indicates reduction in hazard rate in favor of Talazoparib+Enzalutamide compared to Placebo+Enzalutamide.","groupDescription":"The following statistical hypotheses was tested to address the primary objectives: H02: HRrPFS+ ≥1 vs H12: HRrPFS+ \\<1, where HRrPFS and HRrPFS+ are the hazard ratios (talazoparib in combination with enzalutamide vs. placebo in combination with enzalutamide) of rPFS based on BICR assessment in the DDR deficient population for Part 2 Cohort 2.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"1-sided","paramType":"Hazard Ratio (HR)","paramValue":"0.447","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA indicates not estimated due to less than half of participants meeting the criterion as of data cutoff date (03 Oct 2022).","groupId":"OG000","lowerLimit":"21.9","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"11.0","upperLimit":"16.7","value":"13.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"200"},{"groupId":"OG001","value":"199"}],"units":"Participants"}],"description":"rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per RECIST 1.1, or death, whichever occurs first. Soft tissue disease status was assessed at regular intervals during the course of the study by CT of chest and CT or MRI of abdomen and pelvis. Results as of 03 Oct 2022 are reported for this outcome measure.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with DDR deficiencies were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 169.86 weeks for both talazoparib and enzalutamide as of 03 Oct 2022).","id":"OG000","title":"Part 2 Participants With DDR Deficiencies: Talazoparib+Enzalutamide"},{"description":"Participants with DDR deficiencies were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 157 weeks for both placebo and enzalutamide as of 03 Oct 2022).","id":"OG001","title":"Part 2 Participants With DDR Deficiencies: Placebo+Enzalutamide"}],"paramType":"MEDIAN","populationDescription":"Included DDR-deficient participants randomized to double-blind study treatment in Part 2 regardless of whether or not treatment was administered.","reportingStatus":"POSTED","timeFrame":"From the start of treatment to the time of first documented progression, or death (maximum up to 38 months)","title":"BICR Assessed rPFS Per RECIST 1.1 in Patients With DDR Deficiencies - Part 2","type":"PRIMARY","unitOfMeasure":"Months"}