{"analyses":[{"ciLowerLimit":"1.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"12.8","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0089","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":"7.2","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"-9.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.6","groupIds":["OG001","OG002"],"nonInferiorityType":"OTHER","pValue":"0.0326","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":"-5.0","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"12.9","upperLimit":"21.4","value":"16.8"},{"groupId":"OG001","lowerLimit":"6.2","upperLimit":"14.0","value":"9.6"},{"groupId":"OG002","lowerLimit":"2.5","upperLimit":"7.6","value":"4.6"}]}]}],"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. Percentage of participants with undetectable PSA 2 years after suspension of treatment at Week 37 due to undetectable PSA was calculated as the number of participants with undetectable PSA 2 years after suspension of treatment at Week 37 due to undetectable PSA divided by the number of participants with treatment suspension 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 treatment suspension.","reportingStatus":"POSTED","timeFrame":"From randomization until 2 years after Week 37 (up to Month 34)","title":"Percentage of Participants With Undetectable Prostate-specific Antigen (PSA) 2 Years After Suspension of Treatment at Week 37 Due to Undetectable PSA","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}