{"analyses":[{"ciLowerLimit":"0.501","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.994","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":"0.045210","paramType":"Hazard Ratio (HR)","paramValue":"0.706","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA = value cannot be estimated due to censored data, insufficient number of participants with events","groupId":"OG000","lowerLimit":"44.45","upperLimit":"NA","value":"NA"},{"comment":"NA = value cannot be estimated due to censored data, insufficient number of participants with events","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"955"},{"groupId":"OG001","value":"554"}],"units":"Participants"}],"description":"Overall Survival (OS) was defined as the time from randomization to death due to any cause.","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 of the first subject to the time approximatively 140 death events were observed (approximately 48 months)","title":"Overall Survival - Primary Analysis","type":"SECONDARY","unitOfMeasure":"months"}