{"analyses":[{"ciLowerLimit":"0.147","ciPctValue":"95","ciUpperLimit":"0.195","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 0.0167 for this analysis.","paramType":"Hazard Ratio (HR)","paramValue":"0.169","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.1","upperLimit":"13.7","value":"11.2"},{"groupId":"OG001","lowerLimit":"2.8","upperLimit":"2.9","value":"2.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"872"},{"groupId":"OG001","value":"845"}],"units":"Participants"}],"description":"Time to PSA progression was defined as the time from randomization to date of first confirmed observation of PSA progression for each patient. For patients with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir was documented, and confirmed 3 or more weeks later. For patients with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above baseline was documented, and confirmed 3 or more weeks later. For patients who did not have confirmed PSA progression at the time of the analysis data cutoff, time to PSA progression was censored at the date of the last PSA assessment showing no evidence of confirmed PSA progression or the analysis data cutoff date, whichever was first. Time to PSA progression 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 randomized.","reportingStatus":"POSTED","timeFrame":"During study period (up to 3 years)","title":"Time to Prostate-specific Antigen (PSA) Progression","type":"SECONDARY","unitOfMeasure":"months"}