{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"13"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"800"},{"groupId":"OG001","value":"399"}],"units":"Participants"}],"description":"Any new post baseline abnormality was defined as any abnormal ECG finding that appeared after baseline assessment which was not seen at the screening or baseline ECG assessment. Where, criteria of abnormality was QTcF interval \\> 470 millisecond (msec). Participants were counted once only for a specific abnormality. This outcome measure was planned to be analysed in double blind phase only. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.","groups":[{"description":"In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).","id":"OG000","title":"Enzalutamide"},{"description":"In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months).","id":"OG001","title":"Placebo: DB Phase"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety population was defined as all randomized participants who received at least 1 dose of study drug.","reportingStatus":"POSTED","timeFrame":"Baseline, up to the end of DB phase or unscheduled visit (up to 24 months)","title":"Number of Participants With Any Newly Clinically Significant Abnormal Finding in Electrocardiogram (ECG)","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Participants"}