{"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":"FG000","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":"FG001","title":"Placebo + Docetaxel"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"6"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"6"}],"type":"Additional primary malignancy"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"12"}],"type":"Non-compliance with study drug"},{"reasons":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"26"}],"type":"Adverse event associated with clinical disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"40"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"131"},{"groupId":"FG001","numSubjects":"276"}],"type":"Progressive disease - clinical progression"},{"reasons":[{"groupId":"FG000","numSubjects":"90"},{"groupId":"FG001","numSubjects":"133"}],"type":"Progressive disease - radiological progression"},{"reasons":[{"groupId":"FG000","numSubjects":"49"},{"groupId":"FG001","numSubjects":"27"}],"type":"Adverse event not associated with clinical disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"5"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"287"},{"groupId":"FG001","numSubjects":"118"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}],"type":"Study drug never administered"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"651"},{"groupId":"FG001","numSubjects":"654"}],"comment":"Randomized: 1306 patients were randomized. One patient was excluded from analysis due to a GCP violation","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"651"},{"groupId":"FG001","numSubjects":"651"}],"type":"Started Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"comment":"Ongoing with treatment","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"651"},{"groupId":"FG001","numSubjects":"654"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"1306 were randomly assigned in a 1:1 ratio to study treatment and 1305 were considered valid for efficacy analyses. A total of 1302 participants started treatment and were included to safety analyses.","recruitmentDetails":"This multinational study was conducted between 30-Nov-2016 First Participant First Visit and 11-Apr-2023 Last Participant Last Visit, in 23 countries/regions:\n\nAustralia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Finland, France, Germany, Israel, Italy, Japan, Mexico, Netherlands, Poland, Russian Federation, South Korea, Spain, Sweden, Taiwan, UK, US"}