{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"190"},{"groupId":"OG001","value":"166"},{"groupId":"OG002","value":"47"}]}],"title":"Treatment Emergent Adverse Events (TEAEs)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"98"},{"groupId":"OG001","value":"66"},{"groupId":"OG002","value":"28"}]}],"title":"Grade 3 or Higher TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"7"}]}],"title":"TEAE Leading to Death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"24"}]}],"title":"Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"7"}]}],"title":"TEAE That Was Primary Reason for Treatment Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"12"}]}],"title":"TEAE Leading to Study Drug Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"}]}],"title":"TEAE Leading to Dose Reduction of Study Drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"7"}]}],"title":"TEAE Leading to Dose Interruption of Study Drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"102"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"13"}]}],"title":"TEAE Related to Study Drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"5"}]}],"title":"Grade 3 or Higher TEAE Related to Study Drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"3"}]}],"title":"Serious TEAE Related to Study Drug"}],"denoms":[{"counts":[{"groupId":"OG000","value":"202"},{"groupId":"OG001","value":"193"},{"groupId":"OG002","value":"51"}],"units":"Participants"}],"description":"An AE was defined as any untoward medical occurrence, temporally associated with use of medicinal product, whether considered related to medicinal product. AE could therefore be any unfavorable \\& unintended sign, symptom, or disease temporally associated with use of a medicinal product. An AE was considered serious if, results in death; is life-threatening; results in persistent disability; results in congenital anomaly; requires inpatient hospitalization; or leads to prolongation of hospitalization; other medically important events. TEAE was defined as AE occurring from time of study drug administration on Day 1 until follow-up visit (28 days after last dose, or one day before date of initiation of cytotoxic chemotherapy or an investigational agent, whichever comes first). AEs were graded using National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Fatal.","groups":[{"description":"Participants received 160 mg of enzalutamide orally once a day during double blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months). This arm represents both double blind and open-label period.","id":"OG000","title":"Enzalutamide"},{"description":"Participants received enzalutamide matching placebo orally once a day during double-blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 18.6 months). This arm represents only double blind period.","id":"OG001","title":"Placebo"},{"description":"Eligible participants who received enzalutamide matching placebo during double-blind period and who provided consent to take part in open-label period, received 160 mg of enzalutamide orally once a day during open-label period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 53.8 months). This arm represents only open-label period.","id":"OG002","title":"Placebo Followed by Enzalutamide"}],"paramType":"NUMBER","populationDescription":"Safety Analysis Set consisted of all randomized participants who received at least 1 dose of study drug.","reportingStatus":"POSTED","timeFrame":"From first dose on Day 1 until 28 days after the last dose of study drug, or one day before the date of initiation of cytotoxic chemotherapy or an investigational agent for treatment of prostate cancer, whichever comes first, up to 123 months and 24 days","title":"Number of Participants With Adverse Events (AE)","type":"SECONDARY","unitOfMeasure":"Participants"}