{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"100","upperLimit":"100","value":"100"},{"groupId":"OG001","lowerLimit":"96.5","upperLimit":"99.9","value":"99.5"},{"groupId":"OG002","lowerLimit":"90.2","upperLimit":"99.8","value":"98.6"},{"groupId":"OG003","lowerLimit":"100","upperLimit":"100","value":"100"}]}],"title":"Day 28"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"85.9","upperLimit":"94.5","value":"91.1"},{"groupId":"OG001","lowerLimit":"79.8","upperLimit":"90.1","value":"85.8"},{"groupId":"OG002","lowerLimit":"71.4","upperLimit":"89.7","value":"82.6"},{"groupId":"OG003","lowerLimit":"80.4","upperLimit":"92.7","value":"87.9"}]}],"title":"Day 364"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"50.9","upperLimit":"69.7","value":"61.0"},{"groupId":"OG001","lowerLimit":"48.7","upperLimit":"67.4","value":"58.7"},{"groupId":"OG002","lowerLimit":"36.3","upperLimit":"63.4","value":"50.7"},{"groupId":"OG003","lowerLimit":"60.9","upperLimit":"83.0","value":"73.8"}]}],"title":"Day 1960"}],"denoms":[{"counts":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"202"},{"groupId":"OG002","value":"69"},{"groupId":"OG003","value":"132"}],"units":"Participants"}],"description":"PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).","dispersionType":"95% Confidence Interval","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":"CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail study (CS21).","reportingStatus":"POSTED","timeFrame":"Until all participants have received at least 5 years of treatment and at a frequency of every 3 months","title":"Percentage of Participants With no Prostate-specific Antigen (PSA) Progression","type":"SECONDARY","unitOfMeasure":"percentage of participants"}