{"analyses":[{"ciLowerLimit":"0.40","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.73","estimateComment":"Cabazitaxel vs Abiraterone Acetate or Enzalutamide","groupDescription":"Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.","groupIds":["OG000","OG001"],"nonInferiorityComment":"A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"P-value from 2-sided stratified log-rank test, stratified for ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization. Significance threshold was at 0.05.","paramType":"Hazard Ratio (HR)","paramValue":"0.54","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.7","upperLimit":"9.2","value":"8.0"},{"groupId":"OG001","lowerLimit":"2.8","upperLimit":"5.1","value":"3.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"126"}],"units":"Participants"}],"description":"Radiographic progression-free survival: time (in months) from randomization to occurrence of any one of following: radiological tumor progressions using response evaluation criteria in solid tumors (RECIST 1.1), progression of bone lesions using Prostate Cancer Working Group 2 (PCWG2) criteria or occurrence of death due to any cause. Progression as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesions (PCWG2 criteria): first bone scan with \\>= 2 new lesions compared to Baseline observed less than (\\<) 12 weeks from randomization and confirmed by a second bone scan performed \\>=6 weeks; first bone scan with \\>=2 new lesions compared to Baseline observed \\>=12 weeks from randomization. In accordance with protocol, data cut-off date for final analysis of this endpoint was the date when 196 rPFS events had occurred. Analysis done by Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received Cabazitaxel 25 mg/m\\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).","id":"OG000","title":"Cabazitaxel"},{"description":"Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).","id":"OG001","title":"Abiraterone Acetate or Enzalutamide"}],"paramType":"MEDIAN","populationDescription":"Analysis was performed on ITT population.","reportingStatus":"POSTED","timeFrame":"From randomization until tumor progression or bone lesion progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)","title":"Radiographic Progression-Free Survival (rPFS)","type":"PRIMARY","unitOfMeasure":"months"}