{"analyses":[{"ciLowerLimit":"0.53","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.75","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":"0.63","statisticalComment":"Stratified by baseline Eastern Cooperative Oncology Group (ECOG) performance status and mean Brief Pain Inventory - Short Form score (Question #3).","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"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":"OG000","lowerLimit":"17.3","upperLimit":"NA","value":"18.4"},{"groupId":"OG001","lowerLimit":"11.3","upperLimit":"15.8","value":"13.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"800"},{"groupId":"OG001","value":"399"}],"units":"Participants"}],"description":"Survival was defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for participants who were lost to follow-up since randomization or not known to have died at the data analysis cut-off date (this included participants who were known to have died after the data analysis cut-off date).","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 study period (up to 101 months)","title":"Overall Survival","type":"PRIMARY","unitOfMeasure":"Months"}