{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"1"}]}],"title":"SBP: >180 mmHg and >40 mmHg Increase from BL"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"0"}]}],"title":"SBP: < 90 mmHg and >30 mmHg Decrease from BL"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"}]}],"title":"DBP: >105 mmHg and >30 mmHg Increase from BL"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"}]}],"title":"DBP: < 50 mmHg and >20 mmHg Decrease from BL"},{"categories":[{"measurements":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"2"}]}],"title":"Any abnormalities in SBP or DBP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"0"}]}],"title":"Heart Rate: > 120 bpm and >30 bpm Increase from BL"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}],"title":"Heart Rate: < 50 bpm and >20 bpm Decrease from BL"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"0"}]}],"title":"Any abnormalities in Heart Rate"}],"denoms":[{"counts":[{"groupId":"OG000","value":"800"},{"groupId":"OG001","value":"399"},{"groupId":"OG002","value":"50"}],"units":"Participants"}],"description":"Criteria for abnormalities in vital signs included: sitting/supine systolic blood pressure (SBP) values: absolute result greater than (\\>) 180 millimeter of mercury (mmHg) and \\>40 mmHg increase from baseline (BL) and less than (\\<) 90 mmHg and \\>30 mmHg decrease from BL; diastolic blood pressure (DBP) values: absolute result \\>105 mmHg and \\>30 mmHg increase from BL and absolute result \\< 50 mmHg and \\>20 mmHg decrease from BL; any abnormalities in SBP or DBP; heart rate values: absolute result \\> 120 beats per minute (bpm) and \\>30 bpm increase from BL and absolute result \\< 50 bpm and \\>20 bpm decrease from BL or any abnormalities in heart rate. 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"},{"description":"Participants who received placebo in DB phase, completed DB Phase and entered in optional OLE Phase, received Enzalutamide capsules 160 mg 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 7.7 months).","id":"OG002","title":"Placebo (DB) /Enzalutamide 160 mg (OLE) 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 safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)","title":"Number of Participants With Clinically Significant Changes in Vital Signs","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Participants"}