{"analyses":[{"ciLowerLimit":"0.33","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.80","groupDescription":"Time to SSE Treatment Comparison","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0026","paramType":"Cox hazard ratio","paramValue":"0.52","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":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"574"},{"groupId":"OG001","value":"576"}],"units":"Participants"}],"description":"Time to first SSE was calculated as the time from randomization to the occurrence of the first SSE. An SSE was defined as radiation to bone, surgery to bone, clinically apparent pathological bone fracture, or spinal cord compression. In participants with no SSE, time to SSE was censored on the last visit date or the date of randomization, whichever occurred last.","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","reportingStatus":"POSTED","timeFrame":"From randomization to the occurrence of the first SSE (maximum duration was 26.6 months)","title":"Time to First Symptomatic Skeletal Event (SSE)","type":"SECONDARY","unitOfMeasure":"months"}