{"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":"FG000","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":"FG001","title":"Placebo"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"86"},{"groupId":"FG001","numSubjects":"48"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"120"},{"groupId":"FG001","numSubjects":"140"}],"type":"Confirmed metastasis"},{"reasons":[{"groupId":"FG000","numSubjects":"59"},{"groupId":"FG001","numSubjects":"99"}],"type":"Judgment of the investigator"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}],"type":"Metastasis by local reading"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"2"}],"type":"Other reason"},{"reasons":[{"groupId":"FG000","numSubjects":"77"},{"groupId":"FG001","numSubjects":"85"}],"type":"Personal reason"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"7"}],"type":"Protocol deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Not treated"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"955"},{"groupId":"FG001","numSubjects":"554"}],"comment":"Randomized","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"591"},{"groupId":"FG001","numSubjects":"170"}],"comment":"Ongoing with treatment","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"364"},{"groupId":"FG001","numSubjects":"384"}],"type":"NOT COMPLETED"}],"title":"Double Blind Treatment"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"11"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Confirmed metastasis"},{"reasons":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"2"}],"type":"Judgment of the investigator"},{"reasons":[{"groupId":"FG000","numSubjects":"138"},{"groupId":"FG001","numSubjects":"27"}],"type":"Metastasis by local reading"},{"reasons":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"4"}],"type":"Other reason"},{"reasons":[{"groupId":"FG000","numSubjects":"60"},{"groupId":"FG001","numSubjects":"8"}],"type":"Personal reason"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}],"type":"Protocol deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}],"type":"Missing"}],"milestones":[{"achievements":[{"comment":"Not all participants from treatment period entered follow-up","groupId":"FG000","numSubjects":"591"},{"comment":"Not all participants from treatment period entered follow-up","groupId":"FG001","numSubjects":"170"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"295"},{"groupId":"FG001","numSubjects":"114"}],"comment":"Moving to roll-over study","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"296"},{"groupId":"FG001","numSubjects":"56"}],"type":"NOT COMPLETED"}],"title":"Open Label"}],"preAssignmentDetails":"From 2696 participants who signed informed consent, 1187 participants were discontinued from screening. A total of 1509 participants were randomly assigned to either darolutamide arm or placebo arm. The study was unblinded on 30 OCT 2018 and participants in the placebo arm could cross over to open-label darolutamide treatment.","recruitmentDetails":"Study was conducted at multiple centers in 36 countries between 12 September 2014 (first participant first visit) and 14 June 2021 (last participant last visit)."}