{"analyses":[{"ciLowerLimit":"20.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"31.0","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"<0.0001","pValueComment":"P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.","paramType":"difference of percentage of participants","paramValue":"25.9","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"13.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"24.6","groupIds":["OG001","OG002"],"nonInferiorityType":"OTHER","pValue":"<0.0001","pValueComment":"P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.","paramType":"difference of percentage of participants","paramValue":"18.8","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"94.9","upperLimit":"98.7","value":"97.3"},{"groupId":"OG001","lowerLimit":"66.3","upperLimit":"76.2","value":"71.4"},{"groupId":"OG002","lowerLimit":"86.5","upperLimit":"93.2","value":"90.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"331"},{"groupId":"OG001","value":"336"},{"groupId":"OG002","value":"337"}],"units":"Participants"}],"description":"Undetectable PSA at 36 weeks was serum PSA levels \\<0.2 ng/mL at Week 36. Percentage of participants with undetectable PSA at 36 weeks on study drug was calculated as the number of participants with undetectable PSA at Week 36 divided by the number of participants with PSA values at Week 36, and multiplied by 100.","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":"NUMBER","populationDescription":"All participants in the ITT population (randomly assigned to study treatment) who had PSA values at Week 36.","reportingStatus":"POSTED","timeFrame":"At Week 36","title":"Percentage of Participants With Undetectable Prostate-specific Antigen (PSA) at 36 Weeks on Study Drug","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}