{"analyses":[{"ciLowerLimit":"0.53","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.81","estimateComment":"Significance level is 0.04. Hazard ratio and 95 % CI are estimated by cox proportional hazards model.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.66","statisticalComment":"P-value from stratified log-rank test.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Not reached. Data was not reached due to low number of events.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Not reached. Data was not reached due to low number of events.","groupId":"OG001","lowerLimit":"49.74","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"574"},{"groupId":"OG001","value":"576"}],"units":"Participants"}],"description":"OS was defined as the time from randomization to death due to any cause. In participants still alive at the date of the analysis cutoff point, OS was censored on the last date the participant was known to be alive. OS was analyzed using Kaplan-Meier estimates.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.","id":"OG000","title":"Enzalutamide + Androgen Deprivation Therapy (ADT)"},{"description":"Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.","id":"OG001","title":"Placebo + Androgen Deprivation Therapy (ADT)"}],"paramType":"MEDIAN","populationDescription":"ITT population","reportingStatus":"POSTED","timeFrame":"From randomization to death due to any cause (maximum duration was 58.6 months)","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"months"}