{"analyses":[{"ciLowerLimit":"0.033","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.141","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","pValueComment":"Statistical significance can be declared if p-value \\<0.02.","paramType":"Hazard Ratio (HR)","paramValue":"0.068","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.226","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.486","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","pValueComment":"Statistical significance can be declared if p-value \\<0.03.","paramType":"Hazard Ratio (HR)","paramValue":"0.331","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 PSA progression was defined as the time in months from randomization to the date of the first PSA value demonstrating progression, while participants were on study treatment, which was subsequently confirmed at least 3 weeks later. PSA progression date was defined as the date that a ≥25% increase and an absolute increase of ≥2 micrograms per liter (μg/L) (2 nanograms per milliliter \\[ng/mL\\]) above the nadir (or baseline for participants with no PSA decline by Week 25) that was confirmed by a second consecutive value at least 3 weeks later. For participants who had suspended treatment at Week 37 and later reinitiated treatment, baseline was reset as the last PSA assessment prior to or on the date of reinitiation of treatment.","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":"The ITT population was used for analysis, and it included all participants randomly assigned to study treatment.","reportingStatus":"POSTED","timeFrame":"From randomization until first PSA progression (up to Month 98)","title":"Time to Prostate-specific Antigen (PSA) Progression","type":"SECONDARY","unitOfMeasure":"Months"}