{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"738"},{"groupId":"OG001","value":"328"}]}],"title":"SBP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"563"},{"groupId":"OG001","value":"229"}]}],"title":"DBP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"}]}],"title":"Heart rate"}],"denoms":[{"counts":[{"groupId":"OG000","value":"930"},{"groupId":"OG001","value":"465"}],"units":"Participants"}],"description":"Vital signs included Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and heart rate.","groups":[{"description":"Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.","id":"OG000","title":"Enzalutamide 160 mg"},{"description":"Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.","id":"OG001","title":"Placebo"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).","reportingStatus":"POSTED","timeFrame":"From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)","title":"Number of Participants With Clinically Significant Vital Signs","type":"SECONDARY","unitOfMeasure":"Participants"}