{"analyses":[{"ciLowerLimit":"0.617","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.239","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":"0.4500","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":"0.874","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.8","upperLimit":"2.9","value":"2.8"},{"groupId":"OG001","lowerLimit":"2.8","upperLimit":"2.8","value":"2.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"125"}],"units":"Participants"}],"description":"Time from date of randomization to the date of first confirmed PSA progression as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2). For participant's whose PSA decreased at Week 13 after randomization, progression was defined as 25 percent (%) PSA increase relative to nadir or absolute increase of \\>=2 nanogram/milliliter (ng/mL) above nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well. For participant's whose PSA did not decrease at Week 13 after randomization, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline. Participants who were not known to have had a PFS event at the analysis date were censored at last PSA assessment date prior to data cutoff date.","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 disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)","title":"Time to Prostate Specific Antigen (PSA) Progression","type":"SECONDARY","unitOfMeasure":"months"}