{"analyses":[{"ciLowerLimit":"0.125","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.548","groupIds":["OG000","OG001"],"nonInferiorityComment":"Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \\< 1 favoring enzalutamide + leuprolide.","nonInferiorityType":"OTHER","pValue":"0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.261","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.226","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.794","groupIds":["OG001","OG002"],"nonInferiorityComment":"Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \\< 1 favoring enzalutamide monotherapy.","nonInferiorityType":"OTHER","pValue":"0.0057","paramType":"Hazard Ratio (HR)","paramValue":"0.423","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA indicates not estimable due to small number of events.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"NA indicates not estimable due to small number of events.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"NA indicates not estimable due to small number of events.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"355"},{"groupId":"OG001","value":"358"},{"groupId":"OG002","value":"355"}],"units":"Participants"}],"description":"Time to first symptomatic skeletal event was defined as the time in months from randomization to use of radiation therapy (external beam radiation therapy or radionuclides) or surgery to bone for prostate cancer, findings of clinically apparent pathologic bone fracture or of spinal cord compression, or new use of opiate and/or systemic antineoplastic therapy due to bone pain collected in the SSE case report form (CRF), whichever occurred first.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were randomized to receive enzalutamide capsules 160 milligrams (mg)/day, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory prostate-specific antigen (PSA) evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.","id":"OG000","title":"Enzalutamide + Leuprolide"},{"description":"Participants were randomized to receive placebo capsules once daily, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.","id":"OG001","title":"Placebo + Leuprolide"},{"description":"Participants were randomized to receive enzalutamide capsules 160 mg/day from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.","id":"OG002","title":"Enzalutamide Monotherapy"}],"paramType":"MEDIAN","populationDescription":"ITT population was used for analysis, and it included all participants randomly assigned to study treatment.","reportingStatus":"POSTED","timeFrame":"From randomization until the first development of events defined as SSE (up to Month 98)","title":"Time to First Symptomatic Skeletal Event (SSE)","type":"SECONDARY","unitOfMeasure":"Months"}