{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"}]}],"title":"Diastolic blood pressure <=50 and decrease >=15"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"0"}]}],"title":"Diastolic blood pressure >=105 and increase >=15"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"}]}],"title":"Systolic blood pressure <=90 and decrease >=20"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"4"}]}],"title":"Systolic blood pressure >=180 and increase >=20"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"2"}]}],"title":"Heart rate <=50 and decrease >=15"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"3"}]}],"title":"Heart rate >=120 and increase >=15"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"21"},{"groupId":"OG003","value":"8"}]}],"title":"Body weight decrease of >=7 percent"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"5"}]}],"title":"Body weight increase of >=7 percent"}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"126"},{"groupId":"OG002","value":"69"},{"groupId":"OG003","value":"66"}],"units":"Participants"}],"description":"This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.","groups":[{"description":"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.","id":"OG000","title":"Degarelix 80 mg / Degarelix 80 mg"},{"description":"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.\n\nFollowing the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.","id":"OG001","title":"Degarelix 160 mg / Degarelix 160 mg"},{"description":"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.\n\nStarting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.\n\nFollowing the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.","id":"OG002","title":"Leuprolide 7.5 mg / Degarelix 80 mg"},{"description":"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.\n\nStarting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.\n\nFollowing the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.","id":"OG003","title":"Leuprolide 7.5 mg / Degarelix 160 mg"}],"paramType":"NUMBER","populationDescription":"The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.","reportingStatus":"POSTED","timeFrame":"Up to 4 years of treatment","title":"Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight","type":"PRIMARY","unitOfMeasure":"participants"}