{"analyses":[{"ciLowerLimit":"0.516","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.718","groupIds":["OG000","OG001"],"nonInferiorityComment":"Hazard ratio \\< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).","nonInferiorityType":"SUPERIORITY","otherAnalysisDescription":"One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).","pValue":"<0.0001","pValueComment":"One-sided p-value.","paramType":"Hazard Ratio (HR)","paramValue":"0.609","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA = Value cannot be estimated due to censored data","groupId":"OG000","lowerLimit":"47.2","upperLimit":"NA","value":"51.2"},{"groupId":"OG001","lowerLimit":"36.0","upperLimit":"42.3","value":"39.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"651"},{"groupId":"OG001","value":"654"}],"units":"Participants"}],"description":"Symptomatic skeletal event-free survival (SSE-FS) was defined as the time from randomization to the first occurrence of an SSE or death from any cause, whichever occurred first.\n\nTreatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.\n\nNA = Value cannot be estimated due to censored data","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.","id":"OG000","title":"Darolutamide (BAY1841788) + Docetaxel"},{"description":"Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.","id":"OG001","title":"Placebo + Docetaxel"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"From randomization of the first participant to the first occurrence of an SSE event or death from any cause, whichever occurred first up to 25 OCT 2021 cut-off date approximately 59 months","title":"Symptomatic Skeletal Event Free Survival (SSE-FS) - Month","type":"SECONDARY","unitOfMeasure":"Months"}