{"analyses":[{"ciLowerLimit":"19.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"57.0","estimateComment":"Confidence Interval based on standard normal approximation.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0079","paramType":"Difference in Rate of Pain Palliation","paramValue":"38.2","statisticalComment":"Stratified by baseline Eastern Cooperative Oncology Group performance status (0-1 vs. 2).","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"30.7","upperLimit":"59.8","value":"44.9"},{"groupId":"OG001","lowerLimit":"0.2","upperLimit":"31.9","value":"6.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"description":"The proportion of participants with pain palliation was assessed for participants with a stable and sufficient pain burden at study entry. Pain burden was measured by question #3 of the Brief Pain Inventory (Short Form). This scale measures pain on a 0 to 10 scale with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Pain palliation at Week 13 was determined for the proportion of men with baseline bone metastasis(es) who had baseline pain attributable to the metastasis(es). Palliation was defined as \\>=30% reduction in average pain score at Week 13 compared to baseline without a \\>=30% increase in analgesic use.","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 ITT Population included participants with metastatic bone disease at baseline; provided answers to Question #3 of the Brief Pain Inventory - Short Form for a minimum of 4 out of 7 days in the baseline run-in period; stable baseline pain; stable analgesic use; and had an average pain score during the baseline run-in period of \\>= 4.","reportingStatus":"POSTED","timeFrame":"Baseline up to 24 months","title":"Percentage of Participants With Pain Palliation","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}