{"analyses":[{"ciLowerLimit":"0.596","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.837","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":"A 2-stage group sequential method (Lan DeMets OBF) assigned the level of significance for the pre-specified interim overall survival analysis (p\\<0.015) based on overall 2-sided type I error rate of 0.049. Final results based upon interim analysis.","paramType":"Hazard Ratio (HR)","paramValue":"0.706","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.","groupId":"OG000","lowerLimit":"30.1","upperLimit":"NA","value":"32.4"},{"comment":"The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.","groupId":"OG001","lowerLimit":"28.0","upperLimit":"NA","value":"30.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"872"},{"groupId":"OG001","value":"845"}],"units":"Participants"}],"description":"Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization.","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.","reportingStatus":"POSTED","timeFrame":"During study period (up to 3 years)","title":"Overall Survival","type":"PRIMARY","unitOfMeasure":"months"}