{"analyses":[{"ciLowerLimit":"0.974","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.24","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":"1.099"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.79","upperLimit":"3.45","value":"2.9"},{"groupId":"OG001","lowerLimit":"3.12","upperLimit":"3.94","value":"3.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"598"},{"groupId":"OG001","value":"602"}],"units":"Participants"}],"description":"PFS was evaluated from date of randomization to date of first documentation of any of the events: 1) Radiological tumor progression: as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target lesions, 2) Prostate Specific Antigen (PSA) progression: ≥25% increase over baseline/nadir value if baseline PSA ≥10 ng/mL; or 25% increase above the baseline level if baseline PSA \\>0 ng/mL \\& \\<10 ng/mL; or post-baseline value of \\>=2 ng/mL, if baseline PSA=0 ng/mL, 3) Pain progression: increase of ≥1 point in median Present Pain Intensity (PPI) from nadir or ≥25% increase in mean analgesic score (AS) from baseline score or requirement of local palliative radiotherapy, 4) Death. 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 tumor progression, PSA progression, pain progression, death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)","title":"Progression Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}