{"analyses":[{"ciLowerLimit":"0.577","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.834","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":"0.693","statisticalMethod":"Log Rank"},{"ciLowerLimit":"1.381","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.984","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":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"1.655","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"17.2","upperLimit":"22.3","value":"19.6"},{"groupId":"OG001","lowerLimit":"14.3","upperLimit":"17.1","value":"16.8"},{"groupId":"OG002","lowerLimit":"8.9","upperLimit":"11.5","value":"10.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"321"},{"groupId":"OG001","value":"240"},{"groupId":"OG002","value":"304"}],"units":"Participants"}],"description":"Undetectable PSA at 36 weeks was serum PSA levels \\<0.2 ng/mL at Week 36. At Week 37, study treatment was suspended for participants whose PSA values were undetectable (\\<0.2 ng/mL) at Week 36 as determined by the central laboratory. Study treatment may have been suspended only once (at Week 37) due to undetectable PSA and was reinitiated if subsequent central laboratory PSA values increased to ≥2.0 ng/mL for participants with prior prostatectomy or ≥5.0 ng/mL for participants without prostatectomy. The time to resumption of any hormonal therapy following suspension at Week 37 due to undetectable PSA was defined as the time in months between the date of treatment suspension at Week 37 due to undetectable PSA and the date that hormonal therapy was restarted.","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":"All participants in the ITT population (randomly assigned to study treatment) who had treatment suspension.","reportingStatus":"POSTED","timeFrame":"From treatment suspension at Week 37 until resumption of any hormonal therapy (up to Month 98)","title":"Time to Resumption of Any Hormonal Therapy Following Suspension at Week 37 Due to Undetectable Prostate-specific Antigen (PSA)","type":"SECONDARY","unitOfMeasure":"Months"}