{"analyses":[{"ciLowerLimit":"0.616","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.204","estimateComment":"Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\\>=0% to \\<30% vs \\>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \\< 1 favoring Enzalutamide.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.3818","pValueComment":"P-value was based on log-rank test stratified by PSA response (\\>=0% to \\<30% vs \\>=30%) at Week 13 in the open-label period.","paramType":"Hazard Ratio (HR)","paramValue":"0.861","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.7","upperLimit":"12.1","value":"10.3"},{"groupId":"OG001","lowerLimit":"7.4","upperLimit":"11.7","value":"8.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"125"}],"units":"Participants"}],"description":"It was defined as time from randomization to the date of first use of subsequent antineoplastic therapy for prostate cancer. For participants who had not started subsequent antineoplastic therapy as of data analysis cutoff date, the time to first use of subsequent antineoplastic therapy was censored at the date of last assessment.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.","id":"OG000","title":"Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg"},{"description":"Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.","id":"OG001","title":"Placebo+Abiraterone 1000mg+ Prednisone 10mg"}],"paramType":"MEDIAN","populationDescription":"ITT population included all participants randomly assigned to study treatment.","reportingStatus":"POSTED","timeFrame":"From randomization until date of first use of any antineoplastic therapy (after last dose date of Period 2, maximum up to 22.3 months","title":"Time to First Use of New Antineoplastic Therapy for Prostate Cancer","type":"SECONDARY","unitOfMeasure":"months"}