{"analyses":[{"ciLowerLimit":"18.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"30.9","estimateComment":"Confidence Interval based on standard normal approximation.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","paramType":"Difference in Percentage of Participants","paramValue":"24.9","statisticalComment":"Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"39.3","upperLimit":"47.1","value":"43.2"},{"groupId":"OG001","lowerLimit":"13.8","upperLimit":"23.6","value":"18.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"651"},{"groupId":"OG001","value":"257"}],"units":"Participants"}],"description":"The FACT-P was a 39-item participant questionnaire which assessed physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items were scored from 0 (not at all) to 4 (very much). The sum of scores on all 5 domains constitutes the global FACT-P. The global/total FACT-P score ranged from 0 (worst) to 156 (best), higher scores indicate better health status. Responders were those participants who had a 10-point improvement in their total FACT-P score, as compared with baseline, on two consecutive measurements obtained at least 3 weeks apart.","dispersionType":"95% Confidence Interval","groups":[{"description":"In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).","id":"OG000","title":"Enzalutamide"},{"description":"In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months in DB Phase and 7.7 months in OLE Phase).","id":"OG001","title":"Placebo"}],"paramType":"NUMBER","populationDescription":"Evaluable intent to treat (ITT) - all participants who were part of the ITT population and had a global FACT-P score at baseline and at least 1 post-baseline assessment.","reportingStatus":"POSTED","timeFrame":"Baseline up to 24 months","title":"Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P)","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}