{"analyses":[{"ciLowerLimit":"0.33","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.55","estimateComment":"Estimated by use of Cox proportional hazards model.","groupDescription":"PFS on based investigator assessment Enzalutamide Vs. Bicalutamide.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.42","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.8","upperLimit":"19.4","value":"15.3"},{"groupId":"OG001","lowerLimit":"5.4","upperLimit":"8.1","value":"5.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"191"}],"units":"Participants"}],"description":"PFS was calculated as the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by investigators, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first. Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan. A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain. The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.","id":"OG000","title":"Enzalutamide"},{"description":"Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.","id":"OG001","title":"Bicalutamide"}],"paramType":"MEDIAN","populationDescription":"Full analysis set","reportingStatus":"POSTED","timeFrame":"From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.","title":"PFS Based on Investigator Assessment","type":"SECONDARY","unitOfMeasure":"months"}