{"analyses":[{"ciLowerLimit":"0.149","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.231","estimateComment":"The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \\< 1 favoring enzalutamide.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","pValueComment":"The assigned 2-sided type I error rate was 0.001 for the analysis of radiographic progression-free survival.","paramType":"Hazard Ratio (HR)","paramValue":"0.186","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The median time to radiographic progression-free survival and its upper 95% confidence limit were not yet reached in the enzalutamide group because an insufficient number of patients had an event at the time of analysis.","groupId":"OG000","lowerLimit":"13.8","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"3.7","upperLimit":"5.4","value":"3.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"832"},{"groupId":"OG001","value":"801"}],"units":"Participants"}],"description":"Radiographic progression-free survival was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause within 168 days after treatment discontinuation, whichever was first. Radiographic disease progression was evaluated by CT scan or MRI and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using RECIST 1.1 for soft tissue disease and PCWG2 guidelines for bone disease. Patients who did not reach the endpoint were censored at their last assessment.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.","id":"OG000","title":"Enzalutamide"},{"description":"Participants received placebo, administered as four capsules, once per day by mouth.","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"Intent to Treat (ITT) - All patients randomly assigned to treatment excluding 84 patients who were not randomized before the radiographic Progression-free Survival data cutoff date of 06 May 2012.","reportingStatus":"POSTED","timeFrame":"During study period (up to 20 months)","title":"Radiographic Progression-free Survival (rPFS)","type":"PRIMARY","unitOfMeasure":"months"}