{"analyses":[{"ciLowerLimit":"0.303","ciPctValue":"95","ciUpperLimit":"0.403","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 Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.0125 for this analysis.","paramType":"Hazard Ratio (HR)","paramValue":"0.349","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":"25.8","upperLimit":"NA","value":"28.0"},{"groupId":"OG001","lowerLimit":"9.7","upperLimit":"12.2","value":"10.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"872"},{"groupId":"OG001","value":"845"}],"units":"Participants"}],"description":"The time to initiation of cytotoxic chemotherapy is defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for the treatment of prostate cancer for each patient. For patients who did not start cytotoxic chemotherapy at the time of the analysis data cutoff, time to initiation of cytotoxic chemotherapy was censored at the date of last assessment where no cytotoxic chemotherapy was indicated or at the analysis data cutoff date, whichever was first. Time to initiation of cytotoxic chemotherapy for patients with no postbaseline assessments was 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":"Time to Initiation of Cytotoxic Chemotherapy","type":"SECONDARY","unitOfMeasure":"months"}