{"analyses":[{"ciLowerLimit":"1.025","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.393","estimateComment":"Cabazitaxel 20 mg/m\\^2 vs Cabazitaxel 25 mg/m\\^2","groupDescription":"Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Hazard Ratio (HR)","paramValue":"1.195"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.96","upperLimit":"6.47","value":"5.7"},{"groupId":"OG001","lowerLimit":"6.11","upperLimit":"7.46","value":"6.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"598"},{"groupId":"OG001","value":"602"}],"units":"Participants"}],"description":"Time to PSA progression was time interval between randomization \\& first occurrence of PSA progression. PSA progression defined as: 1) PSA responders (\\>50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over nadir value, confirmed by second PSA ≥3 weeks later; 2) PSA non-responders (did not achieve \\>50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over baseline value, confirmed by second PSA ≥3 weeks later; 3) In participants not eligible for PSA response (baseline PSA \\<10 ng/mL): (a) participants with baseline PSA \\>0 ng/mL \\& \\<10 ng/mL: increase in PSA by 25% (≥2 ng/mL) above baseline level, confirmed by second PSA value ≥3 weeks apart; (b) participants with baseline value=0 ng/mL: post-baseline PSA value ≥2 ng/mL. Note (for 1-3): Rise in PSA in first 12 weeks was progression only if met definition above and was associated with other sign of DP or if it continued beyond 12 weeks. Analysis was performed by Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Cabazitaxel 20 mg/m\\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.","id":"OG000","title":"Cabazitaxel 20 mg/m^2"},{"description":"Cabazitaxel 25 mg/m\\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.","id":"OG001","title":"Cabazitaxel 25 mg/m^2"}],"paramType":"MEDIAN","populationDescription":"Analysis was performed on ITT population.","reportingStatus":"POSTED","timeFrame":"From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)","title":"Time to PSA Progression","type":"SECONDARY","unitOfMeasure":"months"}