{"analyses":[{"ciLowerLimit":"0.695","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.192","estimateComment":"Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \\< 1 favoring enzalutamide.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.4945","pValueComment":"This secondary endpoint was not adjusted for multiple comparisons.","paramType":"Hazard Ratio (HR)","paramValue":"0.910","statisticalComment":"P-value is based on a log-rank test stratified by disease stage at study entry.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.3","upperLimit":"11.4","value":"8.4"},{"groupId":"OG001","lowerLimit":"6.1","upperLimit":"11.1","value":"8.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"198"},{"groupId":"OG001","value":"198"}],"units":"Participants"}],"description":"The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess patient 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 (0 to 156) with higher scores representing better quality of life. 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. 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 received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.","id":"OG000","title":"Enzalutamide"},{"description":"Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.","id":"OG001","title":"Bicalutamide"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat population: all participants randomly assigned to study treatment.","reportingStatus":"POSTED","timeFrame":"From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.","title":"Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P)","type":"SECONDARY","unitOfMeasure":"months"}