{"analyses":[{"ciLowerLimit":"0.78","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.07","groupDescription":"Time to Pain Progression Based on BPI-SF Treatment Comparison","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2715","paramType":"Cox hazard ratio","paramValue":"0.92","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.25","upperLimit":"10.91","value":"8.3"},{"groupId":"OG001","lowerLimit":"5.65","upperLimit":"8.38","value":"8.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"574"},{"groupId":"OG001","value":"576"}],"units":"Participants"}],"description":"Time to pain progression was defined as time from randomization to the first pain progression event. Pain progression was defined as an increase of ≥ 30% from baseline in the average BPI-SF pain severity score. BPI-SF contains 9 questions with rating scales from 0 (no pain/no interference) to 10 (worst pain/interferes completely). Total score was calculated as the average of each question. Higher scores represent a higher level of pain or interference. In participants with no pain progression event, time to pain progression was censored on the last visit date where BPI-SF was collected.","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 randomization to the first pain progression event (maximum duration was 26.6 months)","title":"Time to Pain Progression Based on Brief Pain Inventory-Short Form (BPI-SF)","type":"SECONDARY","unitOfMeasure":"months"}