{"analyses":[{"ciLowerLimit":"0.287","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.815","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":"0.005294","paramType":"Hazard Ratio (HR)","paramValue":"0.484","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":"NA","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":"The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE. The final analysis was done at the time of the data cut-off (15 NOV 2019).","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 occurrence of first SSE event (approximately 59 months)","title":"Time to First Symptomatic Skeletal Event (SSE) - Final Analysis","type":"SECONDARY","unitOfMeasure":"months"}