{"analyses":[{"ciLowerLimit":"0.204","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.303","estimateComment":"Hazard Ratio and 95% confidence interval are from Cox regression model.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).","paramType":"Hazard Ratio (HR)","paramValue":"0.248","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.8","upperLimit":"8.3","value":"8.3"},{"groupId":"OG001","lowerLimit":"2.9","upperLimit":"3.7","value":"3.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"800"},{"groupId":"OG001","value":"399"}],"units":"Participants"}],"description":"Time to PSA progression was defined as time from randomization to PSA progression. Participants who did not reach the endpoint were right censored at their last assessment or for participants with no post-baseline PSA assessment, date of randomization. For participants with PSA declines at Week 13, the PSA progression date was defined as the date that a \\>=25% increase and an absolute increase of \\>=2 nanogram per milliliter (ng/mL) above the nadir was documented, which was confirmed by a second consecutive value obtained 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment). For participants with no PSA declines at Week 13, PSA progression date was defined as the date that a \\>=25% increase and an absolute increase of \\>=2 ng/mL above the baseline was documented, which was confirmed by a second consecutive value 3 or more weeks later (required only if PSA progression did not occur at last PSA 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":"Baseline and at every study visit from Week 13 while on study drug (up to 24 months)","title":"Time to Prostate-specific Antigen (PSA) Progression","type":"SECONDARY","unitOfMeasure":"Months"}