{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"649"},{"groupId":"OG001","value":"643"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"306"},{"groupId":"OG001","value":"276"}]}],"title":"TESAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"172"},{"groupId":"OG001","value":"112"}]}],"title":"TEAE leading to study drug dose modification"},{"categories":[{"measurements":[{"groupId":"OG000","value":"90"},{"groupId":"OG001","value":"69"}]}],"title":"TEAE leading to permanent discontinuation of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"216"},{"groupId":"OG001","value":"214"}]}],"title":"TEAE leading to docetaxel dose modification"},{"categories":[{"measurements":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"67"}]}],"title":"TEAE leading to permanent discontinuation of docetaxel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"64"}]}],"title":"Related to protocol-required procedure"},{"categories":[{"measurements":[{"groupId":"OG000","value":"344"},{"groupId":"OG001","value":"309"}]}],"title":"Any study drug-related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"24"}]}],"title":"Study drug-related TESAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"41"}]}],"title":"Study drug-related TEAE leading to study drug dose modification"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"13"}]}],"title":"Study drug-related TEAE leading to permanent discontinuation of study drug"}],"denoms":[{"counts":[{"groupId":"OG000","value":"652"},{"groupId":"OG001","value":"650"}],"units":"Participants"}],"description":"TEAEs = Treatment-emergent adverse events, were defined as any event(s) arising or worsening after the first dose of darolutamide or placebo, until 30 days after the last dose of darolutamide or placebo administration.","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","populationDescription":"The number of patients who started treatment is presented based on the randomized treatment assignment. One patient was randomized to the placebo+docetaxel arm but received at least one dose of darolutamide. This patient was included in the darolutamide+docetaxel arm in the analysis of all safety variables.","reportingStatus":"POSTED","timeFrame":"From the first dose of darolutamide or placebo until 30 days after the last dose of darolutamide or placebo administration up to cut-off date for the final completion analysis 11 APR 2023 (approximately 77 months)","title":"Number of Participants With TEAEs","type":"SECONDARY","unitOfMeasure":"Participants"}