{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"465"},{"groupId":"OG001","value":"318"},{"groupId":"OG002","value":"129"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"871"},{"groupId":"OG001","value":"844"},{"groupId":"OG002","value":"234"}],"units":"Participants"}],"description":"An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug up to a maximum duration of 6.5 years. Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.","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) Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria for AEs (CTCAE), Version 4.0","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Participants"}