{"analyses":[{"ciLowerLimit":"0.72","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.08","estimateComment":"Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.","groupDescription":"Time to Deterioration of Urinary Symptoms Treatment Comparison","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2162","pValueComment":"Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.","paramType":"Cox hazard ratio","paramValue":"0.88","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Not reached. Data was not reached due to low number of events.","groupId":"OG000","lowerLimit":"19.35","upperLimit":"NA","value":"NA"},{"comment":"Not reached. Data was not reached due to low number of events.","groupId":"OG001","lowerLimit":"14.06","upperLimit":"NA","value":"16.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"574"},{"groupId":"OG001","value":"576"}],"units":"Participants"}],"description":"In participants with deterioration, the time to deterioration was calculated as the time interval between randomization and the first deterioration in urinary symptoms at any postbaseline visit. A deterioration in urinary symptoms was defined as an increase in the Quality of Life Prostate-specific Questionnaire (QLQ-PR25) modified urinary symptoms. Subscale score by ≥ 50% of the standard deviation observed in the QLQ-PR25 modified urinary symptoms subscale score at baseline. Modified urinary symptoms subscale score consisted of 3-items (Q31 - Q33) from the QLQ-PR25, each scored from 1 (not at all) to 4 (very much). The total modified urinary symptoms subscale score ranges from 0-100, with higher scores represents a higher level of symptomatology/problems. In participants without deterioration in urinary symptoms, the time to deterioration in urinary symptoms was censored on the date the last urinary symptoms QLQ-PR25 score was calculable.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.","id":"OG000","title":"Enzalutamide + Androgen Deprivation Therapy (ADT)"},{"description":"Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.","id":"OG001","title":"Placebo + Androgen Deprivation Therapy (ADT)"}],"paramType":"MEDIAN","populationDescription":"ITT","reportingStatus":"POSTED","timeFrame":"From date of randomization to the first deterioration in urinary symptoms at any postbaseline visit (maximum duration was 26.6 months)","title":"Time to Deterioration in Urinary Symptoms","type":"SECONDARY","unitOfMeasure":"months"}