{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"857"},{"groupId":"OG001","value":"791"},{"groupId":"OG002","value":"212"}]}],"title":"AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"384"},{"groupId":"OG001","value":"229"},{"groupId":"OG002","value":"104"}]}],"title":"SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"871"},{"groupId":"OG001","value":"844"},{"groupId":"OG002","value":"234"}],"units":"Participants"}],"description":"An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the 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/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to a maximum of 6.5 years that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.","groups":[{"description":"Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.","id":"OG000","title":"Enzalutamide"},{"description":"Participants received placebo, administered as four capsules, once per day by mouth.","id":"OG001","title":"Placebo"},{"description":"Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.","id":"OG002","title":"Placebo Participants Crossover to Enzalutamide"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety analysis set included all randomized participants who received at least 1 dose or partial dose of study drug.","reportingStatus":"POSTED","timeFrame":"Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)","title":"Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Participants"}