{"analyses":[{"ciLowerLimit":"0.954","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.357","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":"0.1567","paramType":"Hazard Ratio (HR)","paramValue":"1.138","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.981","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.391","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":"0.0855","paramType":"Hazard Ratio (HR)","paramValue":"1.168","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.7","upperLimit":"11.1","value":"8.3"},{"groupId":"OG001","lowerLimit":"8.3","upperLimit":"14.0","value":"11.1"},{"groupId":"OG002","lowerLimit":"5.8","upperLimit":"13.0","value":"8.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"355"},{"groupId":"OG001","value":"358"},{"groupId":"OG002","value":"355"}],"units":"Participants"}],"description":"Time to first deterioration of the FACT-P total score was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the FACT-P total score. FACT-P total score is based on subscale scores of physical, social/family, emotional, and functional well-being, as well as 12 site-specific items to assess prostate-related symptoms, ranging 0-156, with higher score representing better quality of life.","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":"ITT population was used for analysis, and it included all participants randomly assigned to study treatment.","reportingStatus":"POSTED","timeFrame":"From randomization to first assessment with at least a 10-point decrease from baseline in the FACT-P total score (up to Month 98)","title":"Time From Randomization to First Assessment With at Least a 10-point Decline (Deterioration) From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score","type":"SECONDARY","unitOfMeasure":"Months"}