{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"108"}]}],"title":"Number (%) of patients with event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"556"},{"groupId":"OG001","value":"546"}]}],"title":"Number (%) of patients censored"}],"denoms":[{"counts":[{"groupId":"OG000","value":"651"},{"groupId":"OG001","value":"654"}],"units":"Participants"}],"description":"Time to the first SSE was defined as the time from randomization to the first occurrence of an SSE. Identical to the definition used for SSE-FS. Death was not considered as an event in this endpoint.\n\nTreatment period: treatment was provided for all patients, twice daily, 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.","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":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"From randomization of the first participant to the first occurrence of an SSE event up to 25 OCT 2021 cut-off date approximately 59 months","title":"Time to First Symptomatic Skeletal Event (SSE) - Number of Events","type":"SECONDARY","unitOfMeasure":"Participants"}