{"analyses":[{"ciLowerLimit":"4.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"11.8","estimateComment":"Treatment difference= Relugolix - Leuprolide acetate","groupDescription":"Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of non-inferiority was conducted.","groupIds":["OG000","OG001"],"nonInferiorityComment":"The lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups was calculated with a noninferiority margin of -10%.","nonInferiorityType":"NON_INFERIORITY","paramType":"Treatment difference","paramValue":"7.9"},{"groupDescription":"Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of superiority was conducted.","groupIds":["OG000","OG001"],"nonInferiorityComment":"If non-inferiority was demonstrated, superiority could be claimed if the lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups also excluded 0%. The p value was calculated post hoc.","nonInferiorityType":"SUPERIORITY","pValue":"< 0.0001","statisticalComment":"Two-sided type I error of 0.05.","statisticalMethod":"t-test, 2 sided"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"94.9","upperLimit":"97.9","value":"96.7"},{"groupId":"OG001","lowerLimit":"84.6","upperLimit":"91.8","value":"88.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"622"},{"groupId":"OG001","value":"308"}],"units":"Participants"}],"description":"Sustained castration rate defined as the cumulative probability of testosterone suppression to \\< 50 nanogram (ng)/deciliter (dL). The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.\n\nThe lower bound of the 95% confidence interval (CI) for the cumulative probability of sustained testosterone suppression in the relugolix treatment group must have been ≥ 90% to meet evaluation criteria for efficacy.","dispersionType":"95% Confidence Interval","groups":[{"description":"Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.","id":"OG000","title":"Relugolix"},{"description":"Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.","id":"OG001","title":"Leuprolide Acetate"}],"paramType":"NUMBER","populationDescription":"All randomized participants who received at least 1 dose of study drug.","reportingStatus":"POSTED","timeFrame":"From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)","title":"Sustained Castration Rate","type":"PRIMARY","unitOfMeasure":"percentage of participants"}