{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"96.4"},{"groupId":"OG001","value":"90.4"},{"groupId":"OG002","value":"97.3"}]}],"title":"Any AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16.2"},{"groupId":"OG001","value":"13.1"},{"groupId":"OG002","value":"24.3"}]}],"title":"AE Leading to Study Drug Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.6"},{"groupId":"OG001","value":"3.0"},{"groupId":"OG002","value":"8.1"}]}],"title":"AE Leading to Death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"38.6"},{"groupId":"OG001","value":"30.3"},{"groupId":"OG002","value":"43.2"}]}],"title":"Serious AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"66.5"},{"groupId":"OG001","value":"53.5"},{"groupId":"OG002","value":"70.3"}]}],"title":"AE Related to Study Drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7.6"},{"groupId":"OG001","value":"3.5"},{"groupId":"OG002","value":"2.7"}]}],"title":"Serious AE Related to Study Drug"}],"denoms":[{"counts":[{"groupId":"OG000","value":"197"},{"groupId":"OG001","value":"198"},{"groupId":"OG002","value":"37"}],"units":"Participants"}],"description":"An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. A treatment emergent AE defined as an event that emerged during treatment period (From first dose of study drug until end of open label phase \\[up to maximum duration of 65 months\\]) that was absent before treatment, or worsened during treatment period relative to pre-treatment state. AE included both serious and non- SAE. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An AE was considered related to study drug if event was assessed by investigator as probably or possibly related.","groups":[{"description":"Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, and 1 bicalutamide matching placebo capsule once per day, by mouth for up to 29 months in DB phase. Participants who completed DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules once per day by mouth for up to 36 months in open label phase.","id":"OG000","title":"Enzalutamide"},{"description":"Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide matching placebo capsules for up to 29 months in DB phase.","id":"OG001","title":"DB Phase: Bicalutamide"},{"description":"Participants who received bicalutamide 50 mg in DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth in open label phase for up to 36 months.","id":"OG002","title":"Open Label Phase: Bicalutamide Crossover to Enzalutamide"}],"paramType":"NUMBER","populationDescription":"Safety population included all participants who received at least 1 dose of study drug.","reportingStatus":"POSTED","timeFrame":"From first dose of study drug until the end of open label phase (up to maximum duration of 65 months)","title":"Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}