{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.95","upperLimit":"6.44","value":"4.69"},{"groupId":"OG001","lowerLimit":"3.32","upperLimit":"6.84","value":"5.08"}]}],"title":"Change from baseline at cycle 1 (n =521, 494)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.67","upperLimit":"6.14","value":"4.4"},{"groupId":"OG001","lowerLimit":"3.81","upperLimit":"7.3","value":"5.55"}]}],"title":"Change from baseline at cycle 2 (n = 500, 494)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2","upperLimit":"5.5","value":"3.75"},{"groupId":"OG001","lowerLimit":"3.7","upperLimit":"7.23","value":"5.46"}]}],"title":"Change from baseline at cycle 3 (n =456, 451)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.8","upperLimit":"4.33","value":"2.57"},{"groupId":"OG001","lowerLimit":"2.04","upperLimit":"5.6","value":"3.82"}]}],"title":"Change from baseline at cycle 4 (n =420, 415)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.03","upperLimit":"3.59","value":"1.78"},{"groupId":"OG001","lowerLimit":"1.26","upperLimit":"4.87","value":"3.06"}]}],"title":"Change from baseline at cycle 5 (n =339, 361)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.72","upperLimit":"4.43","value":"2.57"},{"groupId":"OG001","lowerLimit":"0.2","upperLimit":"3.86","value":"2.03"}]}],"title":"Change from baseline at cycle 6 (n =275, 318)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.6","upperLimit":"4.42","value":"2.51"},{"groupId":"OG001","lowerLimit":"0.85","upperLimit":"4.6","value":"2.73"}]}],"title":"Change from baseline at cycle 7 (n =225, 262)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.5","upperLimit":"3.39","value":"1.44"},{"groupId":"OG001","lowerLimit":"0.16","upperLimit":"3.99","value":"2.08"}]}],"title":"Change from baseline at cycle 8 (n =196, 227)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1.06","upperLimit":"2.94","value":"0.94"},{"groupId":"OG001","lowerLimit":"-0.55","upperLimit":"3.46","value":"1.46"}]}],"title":"Change from baseline at cycle 9 (n =165, 172)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2.05","upperLimit":"2.1","value":"0.02"},{"groupId":"OG001","lowerLimit":"-0.76","upperLimit":"3.39","value":"1.31"}]}],"title":"Change from baseline at cycle 10 (n =137, 141)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-4.35","upperLimit":"-0.19","value":"-2.27"},{"groupId":"OG001","lowerLimit":"-3.21","upperLimit":"0.88","value":"-1.16"}]}],"title":"Change from baseline at Follow-up 1 (n =136, 152)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"521"},{"groupId":"OG001","value":"494"}],"units":"Participants"}],"description":"FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P TOI combines physical well-being, functional well-being, and prostate-specific concerns sub-scales for a total possible score range of 0 to 104, where higher values represent better HRQoL.","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":"LEAST_SQUARES_MEAN","populationDescription":"FACT-P population included randomized participants who completed FACT-P questionnaire at baseline \\& in at least one post-baseline assessment. Number of participants analyzed=participants with evaluable FACT-P TOI for specified outcome measure. Here, 'n' signifies number of participants with available data for specified category.","reportingStatus":"POSTED","timeFrame":"Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)","title":"Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL)","type":"SECONDARY","unitOfMeasure":"units on a scale"}