{"groups":[{"description":"In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).","id":"FG000","title":"Enzalutamide"},{"description":"In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months in DB Phase and 7.7 months in OLE Phase).","id":"FG001","title":"Placebo"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"561"},{"groupId":"FG001","numSubjects":"298"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"7"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"108"},{"groupId":"FG001","numSubjects":"42"}],"type":"Study Terminated by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"800"},{"groupId":"FG001","numSubjects":"399"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"109"},{"groupId":"FG001","numSubjects":"50"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"691"},{"groupId":"FG001","numSubjects":"349"}],"type":"NOT COMPLETED"}],"title":"DB Phase (up to 24 Months)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"21"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"78"},{"groupId":"FG001","numSubjects":"26"}],"type":"Study Terminated by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"2"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"109"},{"groupId":"FG001","numSubjects":"50"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"109"},{"groupId":"FG001","numSubjects":"50"}],"type":"NOT COMPLETED"}],"title":"OLE Phase (up to 77 Months)"}],"preAssignmentDetails":"Participants were randomized 2:1 to receive either Enzalutamide or Placebo in DB phase. All participants who continued in OLE phase, received Enzalutamide.","recruitmentDetails":"A total of 1199 participants were enrolled and randomized for double-blind (DB) phase. Out of which, 159 participants entered the optional open-label extension (OLE) phase."}