{"analyses":[{"ciLowerLimit":"0.967","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.025","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":"0.0739","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":"1.399","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.7","upperLimit":"6.5","value":"4.6"},{"groupId":"OG001","lowerLimit":"5.5","upperLimit":"13.9","value":"6.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"125"}],"units":"Participants"}],"description":"Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 with higher scores representing better quality of life. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.","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":"Evaluable ITT population included all participants with a PSA value at baseline of Period 2 and at least 1 post baseline assessment.","reportingStatus":"POSTED","timeFrame":"From randomization up to maximum of 18.4 months","title":"Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score","type":"SECONDARY","unitOfMeasure":"months"}