{"analyses":[{"ciLowerLimit":"0.533","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.785","estimateComment":"The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \\> 6 months) and use of osteoclast-targeted therapy (No, Yes).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.000008","paramType":"Hazard Ratio (HR)","paramValue":"0.647","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"33.21","upperLimit":"41.20","value":"40.31"},{"groupId":"OG001","lowerLimit":"19.09","upperLimit":"29.63","value":"25.36"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"955"},{"groupId":"OG001","value":"554"}],"units":"Participants"}],"description":"Time to pain progression (PP) is defined as time from randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline in question 3 of the Brief Pain Inventory-Short Form questionnaire (BPI-SF) related to the worst pain in the last 24 hours taken as a 7-day average for post-baseline scores, or initiation of short or long-acting opioids for pain, whichever comes first. Initiation or change in the use of other non-opioid analgesics is not used in the analysis of pain progression.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \\[DB\\] + open-label \\[OL\\]).","id":"OG000","title":"Darolutamide (BAY1841788)"},{"description":"Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \\[CO\\]).","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"From randomization until last study treatment (assessed every 4 months) (approximately 48 months)","title":"Time to Pain Progression - Primary Analysis","type":"SECONDARY","unitOfMeasure":"months"}