{"analyses":[{"ciLowerLimit":"0.35","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.47","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":"0.40","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":"8.2","upperLimit":"9.4","value":"8.3"},{"groupId":"OG001","lowerLimit":"2.8","upperLimit":"3.4","value":"2.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"800"},{"groupId":"OG001","value":"399"}],"units":"Participants"}],"description":"Radiographic progression-free survival was defined as time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Participants were assessed for objective disease progression at regularly scheduled visits. The consensus guidelines of the Prostate Cancer Clinical Trials Working Group 2 were taken into consideration for the determination of disease progression. Radiographic disease progression was defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for soft tissue disease, or the appearance of two or more new bone lesions on bone scan. Progression at the first scheduled reassessment at Week 13 required a confirmatory scan 6 or more weeks later. 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":"Radiographic Progression-free Survival","type":"SECONDARY","unitOfMeasure":"Months"}