{"groups":[{"description":"Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.","id":"FG000","title":"Enzalutamide 160 mg"},{"description":"Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.","id":"FG001","title":"Placebo"},{"description":"Participants who received placebo in double-blind phase and who agreed to proceed to open-label phase, received 4 capsules of Enzalutamide 40 mg each (total dose of 160 mg per day), orally once daily (up to a maximum of 18.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.","id":"FG002","title":"Placebo Participants Crossover to Enzalutamide 160 mg"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"71"},{"groupId":"FG001","numSubjects":"47"},{"groupId":"FG002","numSubjects":"0"}],"type":"Withdrawal Consent to Continue Treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"229"},{"groupId":"FG001","numSubjects":"247"},{"groupId":"FG002","numSubjects":"0"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"120"},{"groupId":"FG001","numSubjects":"31"},{"groupId":"FG002","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Randomized But not Treated"},{"reasons":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"50"},{"groupId":"FG002","numSubjects":"0"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"933"},{"groupId":"FG001","numSubjects":"468"},{"groupId":"FG002","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"930"},{"groupId":"FG001","numSubjects":"465"},{"groupId":"FG002","numSubjects":"0"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"478"},{"groupId":"FG001","numSubjects":"87"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"455"},{"groupId":"FG001","numSubjects":"381"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Double-blind Phase"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Withdrawal Consent to Continue Treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"59"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"5"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"10"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"478"},{"comment":"Participants were offered to switch from double blind placebo to open label Enzalutamide.","groupId":"FG001","numSubjects":"0"},{"comment":"Participants previously treated with placebo, switched to receive open label Enzalutamide.","groupId":"FG002","numSubjects":"87"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"478"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"87"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"378"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"70"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"100"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"17"}],"type":"NOT COMPLETED"}],"title":"Open-label Phase"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"288"},{"groupId":"FG001","numSubjects":"174"},{"groupId":"FG002","numSubjects":"4"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"66"},{"groupId":"FG001","numSubjects":"55"},{"groupId":"FG002","numSubjects":"1"}],"type":"Withdrew Consent to Be Followed"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}],"type":"Other"}],"milestones":[{"achievements":[{"comment":"Participants followed up after discontinuing study drug in either double blind or open label phase.","groupId":"FG000","numSubjects":"933"},{"comment":"Participants were followed up after study drug discontinuation in double blind phase.","groupId":"FG001","numSubjects":"381"},{"comment":"Participants were followed up after study drug discontinuation in open label phase.","groupId":"FG002","numSubjects":"87"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"566"},{"groupId":"FG001","numSubjects":"144"},{"groupId":"FG002","numSubjects":"80"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"367"},{"groupId":"FG001","numSubjects":"237"},{"groupId":"FG002","numSubjects":"7"}],"type":"NOT COMPLETED"}],"title":"Long-term Follow-up Phase"}],"preAssignmentDetails":"A protocol amendment was implemented to unblind all participants and those who were previously treated with placebo had an opportunity to receive open-label access to enzalutamide at the discretion of the investigator.","recruitmentDetails":"The study was conducted at 254 sites in 32 countries."}