{"analyses":[{"ciLowerLimit":"0.610","ciPctValue":"95","ciUpperLimit":"0.844","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 0.01 for this analysis.","paramType":"Hazard Ratio (HR)","paramValue":"0.718","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":"29.5","upperLimit":"NA","value":"31.1"},{"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":"23.9","upperLimit":"NA","value":"31.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"872"},{"groupId":"OG001","value":"845"}],"units":"Participants"}],"description":"Time to first skeletal-related event was defined as the time from randomization to the date of the first occurrence of a skeletal-related event for each patient. A skeletal-related event was defined as radiation therapy or surgery to bone for prostate cancer, pathological bone fracture, spinal cord compression, or initiation/change in antineoplastic therapy to treat bone pain from prostate cancer. Skeletal-related events were recorded at each scheduled and unscheduled study visit and during long-term follow-up if a skeletal-related event was not documented previously. Patients who did not have a skeletal-related event at the time of the analysis data cutoff were censored at the date of last assessment indicating no evidence of skeletal-related event. Patients with no postbaseline assessments 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":"Time to First Skeletal-related Event","type":"SECONDARY","unitOfMeasure":"months"}