{"analyses":[{"ciLowerLimit":"0.566","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.835","estimateComment":"Hazard Ratio and 95% confidence interval are from Cox regression model.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.69","statisticalComment":"Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.6","upperLimit":"19.1","value":"16.7"},{"comment":"The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment","groupId":"OG001","lowerLimit":"9.9","upperLimit":"NA","value":"13.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"800"},{"groupId":"OG001","value":"399"}],"units":"Participants"}],"description":"The time to first skeletal-related event was defined as time from randomization to the occurrence of the first skeletal-related event. Participants were assessed for skeletal-related events at regularly scheduled visits. A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain. Participants who did not reach the endpoint were right censored at their last assessment.","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":"MEDIAN","populationDescription":"ITT included all participants who were randomized into the study.","reportingStatus":"POSTED","timeFrame":"During DB Phase (up to 24 months)","title":"Time to First Skeletal-related Event","type":"SECONDARY","unitOfMeasure":"Months"}