{"analyses":[{"ciLowerLimit":"0.40","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.68","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 two-sided stratified log-rank test, stratified for ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.","paramType":"Hazard Ratio (HR)","paramValue":"0.52","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.6","upperLimit":"5.4","value":"4.4"},{"groupId":"OG001","lowerLimit":"2.3","upperLimit":"2.8","value":"2.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"126"}],"units":"Participants"}],"description":"PFS:time duration (in months) from date of randomization to date of first occurrence of any of following events: radiological tumor progression (RECIST 1.1); progression of bone lesions (PCWG2); symptomatic progression (developing urinary or bowel symptoms; need to change anti-cancer therapy), pain progression or death due to any cause. Tumor Progression(RECIST 1.1): at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesion (PCWG2 criteria): first bone scan with \\>=2 new lesions compared to Baseline and confirmed by second bone scan performed \\>=6 weeks later; pain progression: increase by \\>=30% from Baseline in pain intensity score (calculated using scale ranged from 0=no pain to 5=extreme pain) or increase in analgesic usage score \\>=30% (calculated from analgesic use data, non-narcotic medications assigned value of 1 point and narcotic medications assigned 4 points). Analyzed 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, pain progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)","title":"Progression Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}