{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"}]}],"title":"S-Potassium (mmol/L) >=5.8"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}],"title":"S-Alanine aminotransferase (IU/L) >3xULN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"2"}]}],"title":"S-Alkaline phosphatase (IU/L) >3xULN+25% increase"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"2"}]}],"title":"S-Creatinine (µmol/L) >=177"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"5"}]}],"title":"S-Urea nitrogen (mmol/L) >=10.7"},{"categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"47"},{"groupId":"OG002","value":"22"},{"groupId":"OG003","value":"17"}]}],"title":"B-Haematocrit (Ratio) <=0.37"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"6"}]}],"title":"B-Haemoglobin (g/L) <=115"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"}]}],"title":"B-Red blood cell count (10^12/L) <=3.5"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}]}],"title":"B-Eosinophils (%) >=10"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"5"}]}],"title":"B-Lymphocytes (%) <=10"}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"126"},{"groupId":"OG002","value":"69"},{"groupId":"OG003","value":"65"}],"units":"Participants"}],"description":"This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.","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 Safety Laboratory Variables","type":"PRIMARY","unitOfMeasure":"participants"}