{"analyses":[{"ciNumSides":"ONE_SIDED","ciPctValue":"98.89","ciUpperLimit":"1.184","estimateComment":"Cabazitaxel 20 mg/m\\^2 vs Cabazitaxel 25 mg/m\\^2","groupDescription":"The hazard ratio for OS was estimated using the 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. Cabazitaxel 20 mg/m\\^2 relative to 25 mg/m\\^2 dose group was considered non-inferior if the upper bound of 1-sided 98.89% confidence interval of hazard ratio (20 mg/m\\^2 versus 25 mg/m\\^2) was less than the non-inferiority margin of 1.214.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Non-inferiority margin of 1.214","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","paramType":"Hazard Ratio (HR)","paramValue":"1.024"},{"ciLowerLimit":"0.922","ciNumSides":"ONE_SIDED","ciPctValue":"95","estimateComment":"Cabazitaxel 20 mg/m\\^2 vs Cabazitaxel 25 mg/m\\^2","groupDescription":"The hazard ratio for OS was estimated using the 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. Cabazitaxel 25 mg/m\\^2 was considered to be superior to 20 mg/m\\^2 dose if the lower bound of 1-sided 95% confidence interval of hazard ratio was greater than 1.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Hazard Ratio (HR)","paramValue":"1.024"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"12.19","upperLimit":"14.88","value":"13.4"},{"groupId":"OG001","lowerLimit":"13.47","upperLimit":"15.28","value":"14.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"598"},{"groupId":"OG001","value":"602"}],"units":"Participants"}],"description":"OS was defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. 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 Intent-to-Treat (ITT) population, which included all randomized participants.","reportingStatus":"POSTED","timeFrame":"From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)","title":"Overall Survival (OS)","type":"PRIMARY","unitOfMeasure":"months"}