{"groups":[{"description":"Participants who only received enzalutamide 160 mg as four 40 mg capsules, orally once daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.","id":"FG000","title":"Enzalutamide 160 mg"},{"description":"Participants who received (after switching from enzalutamide), in second open label period, abiraterone 1000 mg as four 250 mg tablets, orally once daily and prednisone 10 mg administered as two 5 mg tablets, orally twice daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.","id":"FG001","title":"Enzalutamide 160 mg Crossing Over to Abiraterone 1000 mg+ Prednisone 10 mg"},{"description":"Participants with confirmed prostate-specific antigen (PSA) progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at a 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.","id":"FG002","title":"Enzalutamide 160 mg+ Abiraterone 1000 mg+ Prednisone 10mg"},{"description":"Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at a 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.","id":"FG003","title":"Placebo + Abiraterone 1000 mg+ Prednisone 10 mg"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"34"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"40"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Failure to Achieve PSA response at Week 13"},{"reasons":[{"groupId":"FG000","numSubjects":"92"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Protocol Non-Compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"509"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"264"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"245"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Period 1: First Open Label Treatment"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Disease Progression"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Period 1: Second Open Label Treatment"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"3"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"104"},{"groupId":"FG003","numSubjects":"107"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"14"},{"groupId":"FG003","numSubjects":"5"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"8"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}],"type":"Protocol Non-Compliance"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"126"},{"groupId":"FG003","numSubjects":"125"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"125"},{"groupId":"FG003","numSubjects":"124"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"126"},{"groupId":"FG003","numSubjects":"125"}],"type":"NOT COMPLETED"}],"title":"Period 2: Double Blind Treatment"}],"preAssignmentDetails":"Participants received enzalutamide in first open label treatment period. Participants in second open label treatment period could cross over to receive abiraterone and prednisone. In double blind period participants were randomized to receive treatment with enzalutamide or placebo, each in combination with abiraterone and prednisone."}