{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"6"}]}],"title":"Systolic blood pressure <=90 and decrease >=20"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"23"}]}],"title":"Systolic blood pressure >=180 and increase >=20"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"9"}]}],"title":"Diastolic blood pressure <=50 and decrease >=15"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"8"}]}],"title":"Diastolic blood pressure >=105 and increase >=15"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"9"}]}],"title":"Heart rate <=50 and decrease >=15"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Heart rate >=120 and increase >=15"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"10"}]}],"title":"Body weight decrease of >=7 percent"},{"categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"23"}]}],"title":"Body weight increase of >=7 percent"}],"denoms":[{"counts":[{"groupId":"OG000","value":"202"},{"groupId":"OG001","value":"207"},{"groupId":"OG002","value":"201"}],"units":"Participants"}],"description":"Vital signs and body weight included incidence of markedly abnormal changes from baseline to the end of the study in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.","groups":[{"description":"Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.","id":"OG000","title":"Degarelix 240/160 mg"},{"description":"Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.","id":"OG001","title":"Degarelix 240/80 mg"},{"description":"Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.","id":"OG002","title":"Leuprolide 7.5 mg"}],"paramType":"NUMBER","populationDescription":"ITT population. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes patients whose percent weight change from baseline fit the stated ranges.","reportingStatus":"POSTED","timeFrame":"12 months","title":"Participants With Markedly Abnormal Change in Vital Signs and Body Weight","type":"SECONDARY","unitOfMeasure":"participants"}