{"analyses":[{"ciLowerLimit":"0.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.123","estimateComment":"Cabazitaxel 25 mg/m\\^2 vs Docetaxel 75 mg/m\\^2","groupDescription":"Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Hazard Ratio (HR)","paramValue":"0.948"},{"ciLowerLimit":"0.886","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.238","estimateComment":"Cabazitaxel 20 mg/m\\^2 vs Docetaxel 75 mg/m\\^2","groupDescription":"Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Hazard Ratio (HR)","paramValue":"1.047"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.66","upperLimit":"9.20","value":"8.3"},{"groupId":"OG001","lowerLimit":"7.43","upperLimit":"8.90","value":"8.2"},{"groupId":"OG002","lowerLimit":"8.44","upperLimit":"9.92","value":"9.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"391"},{"groupId":"OG001","value":"389"},{"groupId":"OG002","value":"388"}],"units":"Participants"}],"description":"Time to PSA-PFS: time interval between date of randomization \\& first occurrence of PSA progression/ death, whichever was earlier. PSA progression:1) In PSA responders(≥50% decline from baseline PSA of ≥10 ng/mL):increase of ≥25%(at least 2 ng/mL)over nadir value, confirmed by second PSA value at least 3 weeks later;2)In PSA non-responders(not achieved ≥50% decline from baseline PSA ≥10 ng/mL):increase of ≥25% (at least 2 ng/mL) over baseline value, confirmed by second PSA value at least 3 weeks later;3)In participants not eligible for PSA response(baseline PSA \\<10 ng/mL):(a)in participants with baseline PSA\\>0 ng/mL\\&\\<10 ng/mL: increase in PSA by 25% (at least 2 ng/mL) above baseline level, confirmed by second PSA value at least 3weeks apart;(b)in participants with baseline value=0ng/mL: a post baseline PSA value ≥2ng/mL.Early rise in PSA only indicated progression if it was associated with another sign of DP or if it continued beyond 12 weeks. Analysis performed by Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Docetaxel (TXT) 75 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.","id":"OG000","title":"Docetaxel 75 mg/m^2"},{"description":"Cabazitaxel 20 mg/m\\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.","id":"OG001","title":"Cabazitaxel 20 mg/m^2"},{"description":"Cabazitaxel 25 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.","id":"OG002","title":"Cabazitaxel 25 mg/m^2"}],"paramType":"MEDIAN","populationDescription":"Analysis was performed on ITT population which included all randomized participants.","reportingStatus":"POSTED","timeFrame":"Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)","title":"Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS)","type":"SECONDARY","unitOfMeasure":"months"}