Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-01 @ 6:10 PM
Study NCT ID:
NCT00451958
Status:
COMPLETED
Last Update Posted:
2013-03-21
First Post:
2007-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C431566', 'term': 'acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide'}, {'id': 'D016729', 'term': 'Leuprolide'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DK0-Disclosure@ferring.com', 'title': 'Clinical Development Support', 'organization': 'Ferring Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of CS21A and up to 4.5 years.', 'description': 'The population comprised all participants who were enrolled into CS21A and who received at least one dose of degarelix during the study.', 'eventGroups': [{'id': 'EG000', '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 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.', 'otherNumAtRisk': 207, 'otherNumAffected': 181, 'seriousNumAtRisk': 207, 'seriousNumAffected': 43}, {'id': 'EG001', 'title': 'Degarelix 160 mg / Degarelix 160 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.', 'otherNumAtRisk': 202, 'otherNumAffected': 177, 'seriousNumAtRisk': 202, 'seriousNumAffected': 60}, {'id': 'EG002', '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.', 'otherNumAtRisk': 69, 'otherNumAffected': 63, 'seriousNumAtRisk': 69, 'seriousNumAffected': 23}, {'id': 'EG003', 'title': 'Leuprolide 7.5 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.', 'otherNumAtRisk': 66, 'otherNumAffected': 58, 'seriousNumAtRisk': 66, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injection site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Prostatic specific antigen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 21}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 4}, 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'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Prostate examination abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Malignant lymphoma unclassifiable high grade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pleural mesothelioma malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebrovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperkinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urethral obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Squamus cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'groups': [{'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 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': 'OG001', 'title': 'Degarelix 160 mg / Degarelix 160 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': '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', '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.'}], 'classes': [{'title': 'Diastolic blood pressure <=50 and decrease >=15', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure >=105 and increase >=15', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Systolic blood pressure <=90 and decrease >=20', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Systolic blood pressure >=180 and increase >=20', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Heart rate <=50 and decrease >=15', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Heart rate >=120 and increase >=15', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Body weight decrease of >=7 percent', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Body weight increase of >=7 percent', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 years of treatment', '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', '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.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'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 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': 'OG001', 'title': 'Degarelix 160 mg / Degarelix 160 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': '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', '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.'}], 'classes': [{'title': 'S-Potassium (mmol/L) >=5.8', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'S-Alanine aminotransferase (IU/L) >3xULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'S-Alkaline phosphatase (IU/L) >3xULN+25% increase', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'S-Creatinine (µmol/L) >=177', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'S-Urea nitrogen (mmol/L) >=10.7', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'B-Haematocrit (Ratio) <=0.37', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'B-Haemoglobin (g/L) <=115', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'B-Red blood cell count (10^12/L) <=3.5', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'B-Eosinophils (%) >=10', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'B-Lymphocytes (%) <=10', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 years of treatment', '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', '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.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With no Prostate-specific Antigen (PSA) Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'groups': [{'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 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': 'OG001', 'title': 'Degarelix 160 mg / Degarelix 160 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': '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', '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.'}], 'classes': [{'title': 'Day 28', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '99.5', 'groupId': 'OG001', 'lowerLimit': '96.5', 'upperLimit': '99.9'}, {'value': '98.6', 'groupId': 'OG002', 'lowerLimit': '90.2', 'upperLimit': '99.8'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'Day 364', 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '94.5'}, {'value': '85.8', 'groupId': 'OG001', 'lowerLimit': '79.8', 'upperLimit': '90.1'}, {'value': '82.6', 'groupId': 'OG002', 'lowerLimit': '71.4', 'upperLimit': '89.7'}, {'value': '87.9', 'groupId': 'OG003', 'lowerLimit': '80.4', 'upperLimit': '92.7'}]}]}, {'title': 'Day 1960', 'categories': [{'measurements': [{'value': '61.0', 'groupId': 'OG000', 'lowerLimit': '50.9', 'upperLimit': '69.7'}, {'value': '58.7', 'groupId': 'OG001', 'lowerLimit': '48.7', 'upperLimit': '67.4'}, {'value': '50.7', 'groupId': 'OG002', 'lowerLimit': '36.3', 'upperLimit': '63.4'}, {'value': '73.8', 'groupId': 'OG003', 'lowerLimit': '60.9', 'upperLimit': '83.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until all participants have received at least 5 years of treatment and at a frequency of every 3 months', '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).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail study (CS21).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}]}], 'groups': [{'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 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': 'OG001', 'title': 'Degarelix 160 mg / Degarelix 160 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': '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', 'description': 'During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.\n\nLeuprolide participants who dropped out during the first year (i.e. during CS21) were all attributed to what became the leuprolide 7.5 mg / degarelix 160 mg arm.\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.'}], 'classes': [{'title': 'Day 84', 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '98.6', 'groupId': 'OG002', 'lowerLimit': '90.2', 'upperLimit': '99.8'}, {'value': '97.6', 'groupId': 'OG003', 'lowerLimit': '92.7', 'upperLimit': '99.2'}]}]}, {'title': 'Day 364', 'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000', 'lowerLimit': '93.5', 'upperLimit': '98.8'}, {'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '94.8', 'upperLimit': '99.4'}, {'value': '97.', 'groupId': 'OG002', 'lowerLimit': '88.9', 'upperLimit': '99.3'}, {'value': '96.0', 'groupId': 'OG003', 'lowerLimit': '90.5', 'upperLimit': '98.3'}]}]}, {'title': 'Day 1876', 'categories': [{'measurements': [{'value': '82.0', 'groupId': 'OG000', 'lowerLimit': '72.7', 'upperLimit': '88.4'}, {'value': '87.7', 'groupId': 'OG001', 'lowerLimit': '78.0', 'upperLimit': '93.3'}, {'value': '84.1', 'groupId': 'OG002', 'lowerLimit': '70.2', 'upperLimit': '91.9'}, {'value': '88.4', 'groupId': 'OG003', 'lowerLimit': '75.5', 'upperLimit': '94.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until all participants have received at least 5 years of treatment and at a frequency of every 6 months', 'description': 'The results below present the percentage of participants of having testosterone \\<=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study.\n\nIn all treatment groups approximately 3% per year of the participants had at least one testosterone \\>0.5 ng/mL during the study.', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail CS21 study (NCT00295750).'}, {'type': 'SECONDARY', 'title': 'Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Leuprolide 7.5 mg/ Degarelix 240/80 mg', 'description': 'During the main CS21 study (NCT00295750), 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': 'OG001', 'title': 'Leuprolide 7.5 mg/ Degarelix 240/160 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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.076', 'groupId': 'OG000', 'lowerLimit': '0.015', 'upperLimit': '1.36'}, {'value': '0.074', 'groupId': 'OG001', 'lowerLimit': '0.015', 'upperLimit': '0.229'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.084', 'groupId': 'OG000', 'lowerLimit': '0.015', 'upperLimit': '0.23'}, {'value': '0.068', 'groupId': 'OG001', 'lowerLimit': '0.015', 'upperLimit': '0.19'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.076', 'groupId': 'OG000', 'lowerLimit': '0.015', 'upperLimit': '0.22'}, {'value': '0.066', 'groupId': 'OG001', 'lowerLimit': '0.015', 'upperLimit': '0.16'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.085', 'groupId': 'OG000', 'lowerLimit': '0.015', 'upperLimit': '0.24'}, {'value': '0.073', 'groupId': 'OG001', 'lowerLimit': '0.015', 'upperLimit': '0.27'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0.074', 'groupId': 'OG000', 'lowerLimit': '0.015', 'upperLimit': '0.21'}, {'value': '0.074', 'groupId': 'OG001', 'lowerLimit': '0.015', 'upperLimit': '0.19'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '0.080', 'groupId': 'OG000', 'lowerLimit': '0.015', 'upperLimit': '0.22'}, {'value': '0.077', 'groupId': 'OG001', 'lowerLimit': '0.015', 'upperLimit': '0.16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time of switch to Day 56', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.'}, {'type': 'SECONDARY', 'title': 'Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Leuprolide 7.5 mg/ Degarelix 240/80 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': 'OG001', 'title': 'Leuprolide 7.5 mg/ Degarelix 240/160 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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2938'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1096'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '754'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1059'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '724'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1422'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '671'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1567'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '441'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2008'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '620'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1926'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time of switch to Day 56', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.'}, {'type': 'SECONDARY', 'title': 'Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Leuprolide 7.5 mg/ Degarelix 240/80 mg', 'description': 'During the main CS21 study (NCT00295750), 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': 'OG001', 'title': 'Leuprolide 7.5 mg/ Degarelix 240/160 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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.035', 'groupId': 'OG000', 'lowerLimit': '0.035', 'upperLimit': '1.12'}, {'value': '0.035', 'groupId': 'OG001', 'lowerLimit': '0.035', 'upperLimit': '0.40'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.035', 'groupId': 'OG000', 'lowerLimit': '0.035', 'upperLimit': '0.11'}, {'value': '0.035', 'groupId': 'OG001', 'lowerLimit': '0.035', 'upperLimit': '0.12'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.035', 'groupId': 'OG000', 'lowerLimit': '0.035', 'upperLimit': '0.11'}, {'value': '0.035', 'groupId': 'OG001', 'lowerLimit': '0.035', 'upperLimit': '0.08'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.035', 'groupId': 'OG000', 'lowerLimit': '0.035', 'upperLimit': '0.47'}, {'value': '0.035', 'groupId': 'OG001', 'lowerLimit': '0.035', 'upperLimit': '0.12'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0.035', 'groupId': 'OG000', 'lowerLimit': '0.035', 'upperLimit': '0.16'}, {'value': '0.035', 'groupId': 'OG001', 'lowerLimit': '0.035', 'upperLimit': '0.19'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '0.035', 'groupId': 'OG000', 'lowerLimit': '0.035', 'upperLimit': '0.17'}, {'value': '0.035', 'groupId': 'OG001', 'lowerLimit': '0.035', 'upperLimit': '0.22'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time of switch to Day 56', 'unitOfMeasure': 'International units/Liter (IU/L)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.'}, {'type': 'SECONDARY', 'title': 'Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Leuprolide 7.5 mg/ Degarelix 240/80 mg', 'description': 'During the main CS21 study (NCT00295750), 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': 'OG001', 'title': 'Leuprolide 7.5 mg/ Degarelix 240/160 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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '15.8'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '12.2'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '11.1'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '7.6'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '11.8'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '6.9'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '7.9'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '8.3'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '7.6'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '6.7'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '6.7'}, {'value': '1.55', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '5.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time of switch to Day 56', 'unitOfMeasure': 'International units/Liter (IU/L)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', '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 of the CS21 study (NCT00295750) 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 CS21 study and the current CS21A study.'}, {'id': 'FG001', 'title': 'Degarelix 160 mg / Degarelix 160 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 of the CS21 study (NCT00295750) 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 for the rest of the CS21 study and the current CS21A 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': 'FG002', 'title': 'Leuprolide 7.5 mg / Degarelix 80 mg', 'description': 'During the main CS21 study (NCT00295750), 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': 'FG003', 'title': 'Leuprolide 7.5 mg / Degarelix 160 mg', 'description': 'During the main CS21 study (NCT00295750), 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': 'FG004', 'title': 'Leuprolide 7.5 mg', 'description': 'During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.\n\nWhen the main CS21 study was completed these patients were switched to treatment with degarelix 80 mg or 160 mg in the CS21A study.'}], 'periods': [{'title': 'CS21 (NCT00295750)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'CS21 intention-to-treat (ITT) population.', 'groupId': 'FG000', 'numSubjects': '210'}, {'comment': 'CS21 ITT population.', 'groupId': 'FG001', 'numSubjects': '206'}, {'comment': 'Participants were switched from the leuprolide 7.5 mg group when CS21 was completed.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Participants were switched from the leuprolide 7.5 mg group when CS21 was completed.', 'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '204'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}, {'groupId': 'FG001', 'numSubjects': '163'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '172'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '32'}]}]}, {'title': 'CS21A (NCT00451958)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'CS21A intention-to-treat (ITT) population.', 'groupId': 'FG000', 'numSubjects': '125'}, {'comment': 'CS21A ITT population.', 'groupId': 'FG001', 'numSubjects': '126'}, {'comment': 'CS21A ITT population.', 'groupId': 'FG002', 'numSubjects': '69'}, {'comment': 'One of the enrolled participants never received any treatment, i.e. the CS21A ITT population=65.', 'groupId': 'FG003', 'numSubjects': '66'}, {'comment': 'Participants were switched to the degarelix groups when CS21 was completed.', 'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '39'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Miscellaneous reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All participants who completed the CS21 study (NCT00295750) were eligible to enrol into the CS21A extension study. Since the number of participants who completed this long-term study was low, no firm conclusions can be drawn from the results.', 'preAssignmentDetails': 'Initially, participants treated with degarelix during CS21 continued to treatment and patients who received treatment with leuprolide during CS21 were re-randomised to one of the two degarelix treatment regimens. Following a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg for the rest of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '385', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', '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 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': 'BG001', 'title': 'Degarelix 160 mg / Degarelix 160 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': 'BG002', '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': 'BG003', 'title': 'Leuprolide 7.5 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': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.1', 'spread': '7.62', 'groupId': 'BG000'}, {'value': '71.1', 'spread': '8.25', 'groupId': 'BG001'}, {'value': '72.4', 'spread': '9.46', 'groupId': 'BG002'}, {'value': '71.4', 'spread': '8.24', 'groupId': 'BG003'}, {'value': '71.1', 'spread': '8.29', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'CS21A intention-to-treat (ITT) population.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '385', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'CS21A ITT population.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '106', 'groupId': 'BG004'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'CS21A ITT population.', 'unitOfMeasure': 'participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '78.4', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '79.2', 'spread': '13.4', 'groupId': 'BG001'}, {'value': '78.7', 'spread': '11.3', 'groupId': 'BG002'}, {'value': '80.0', 'spread': '12.1', 'groupId': 'BG003'}, {'value': '79.0', 'spread': '12.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'CS21A ITT population.', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'spread': '3.92', 'groupId': 'BG000'}, {'value': '26.9', 'spread': '3.79', 'groupId': 'BG001'}, {'value': '26.9', 'spread': '3.94', 'groupId': 'BG002'}, {'value': '27.1', 'spread': '3.67', 'groupId': 'BG003'}, {'value': '26.8', 'spread': '3.84', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'CS21A ITT population.', 'unitOfMeasure': 'kilogram per square meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gleason Score', 'classes': [{'title': 'Gleason Score 2-4', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}]}, {'title': 'Gleason Score 5-6', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '124', 'groupId': 'BG004'}]}]}, {'title': 'Gleason Score 7-10', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '208', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'CS21A ITT population. The Gleason Score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive. Two of the participants did not have a Gleason Score at Baseline.', 'unitOfMeasure': 'participants'}, {'title': 'Stage of Prostate Cancer', 'classes': [{'title': 'Localised', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}]}]}, {'title': 'Locally advanced', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '132', 'groupId': 'BG004'}]}]}, {'title': 'Metastatic', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}]}]}, {'title': 'Not classifiable', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'CS21A ITT population. Prostate cancer stage was classified according to the Tumor, Nodes, and Metastatic (TNM) scale to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.', 'unitOfMeasure': 'participants'}, {'title': 'Serum Testosterone Levels', 'classes': [{'categories': [{'measurements': [{'value': '4.63', 'groupId': 'BG000', 'lowerLimit': '1.28', 'upperLimit': '10.6'}, {'value': '4.02', 'groupId': 'BG001', 'lowerLimit': '0.55', 'upperLimit': '10.6'}, {'value': '4.32', 'groupId': 'BG002', 'lowerLimit': '1.34', 'upperLimit': '12.5'}, {'value': '3.51', 'groupId': 'BG003', 'lowerLimit': '0.37', 'upperLimit': '8.00'}, {'value': '4.23', 'groupId': 'BG004', 'lowerLimit': '0.37', 'upperLimit': '12.5'}]}]}], 'paramType': 'MEDIAN', 'description': 'CS21A ITT population.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'FULL_RANGE'}, {'title': 'Serum Prostate-Specific Antigen (PSA) Levels', 'classes': [{'categories': [{'measurements': [{'value': '22.2', 'groupId': 'BG000', 'lowerLimit': '1.70', 'upperLimit': '3187'}, {'value': '22.5', 'groupId': 'BG001', 'lowerLimit': '1.50', 'upperLimit': '4902'}, {'value': '25.5', 'groupId': 'BG002', 'lowerLimit': '1.60', 'upperLimit': '2112'}, {'value': '14.0', 'groupId': 'BG003', 'lowerLimit': '1.60', 'upperLimit': '10952'}, {'value': '21.0', 'groupId': 'BG004', 'lowerLimit': '1.50', 'upperLimit': '10952'}]}]}], 'paramType': 'MEDIAN', 'description': 'CS21A ITT population.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'CS21A intention-to-treat (ITT) population.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 386}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-20', 'studyFirstSubmitDate': '2007-03-23', 'resultsFirstSubmitDate': '2012-10-10', 'studyFirstSubmitQcDate': '2007-03-23', 'lastUpdatePostDateStruct': {'date': '2013-03-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-20', 'studyFirstPostDateStruct': {'date': '2007-03-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight', 'timeFrame': 'Up to 4 years of treatment', '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.'}, {'measure': 'Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables', 'timeFrame': 'Up to 4 years of treatment', '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.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With no Prostate-specific Antigen (PSA) Progression', 'timeFrame': 'Until all participants have received at least 5 years of treatment and at a frequency of every 3 months', '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).'}, {'measure': 'Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards', 'timeFrame': 'Until all participants have received at least 5 years of treatment and at a frequency of every 6 months', 'description': 'The results below present the percentage of participants of having testosterone \\<=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study.\n\nIn all treatment groups approximately 3% per year of the participants had at least one testosterone \\>0.5 ng/mL during the study.'}, {'measure': 'Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56', 'timeFrame': 'From time of switch to Day 56'}, {'measure': 'Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56', 'timeFrame': 'From time of switch to Day 56'}, {'measure': 'Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56', 'timeFrame': 'From time of switch to Day 56'}, {'measure': 'Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56', 'timeFrame': 'From time of switch to Day 56'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Degarelix', 'prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '34350976', 'type': 'DERIVED', 'citation': 'Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion/Exclusion Criteria:\n\n* Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.\n* Signed informed consent\n* The patients must have completed the FE 200486 CS21 Study.'}, 'identificationModule': {'nctId': 'NCT00451958', 'briefTitle': 'A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients With Prostate Cancer Requiring Androgen Ablation Therapy', 'orgStudyIdInfo': {'id': 'FE200486 CS21A'}, 'secondaryIdInfos': [{'id': '2006-006913-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '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 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.', 'interventionNames': ['Drug: Degarelix 80 mg / Degarelix 80 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Degarelix 160 mg / Degarelix 160 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.', 'interventionNames': ['Drug: Degarelix 160 mg / Degarelix 160 mg']}, {'type': 'EXPERIMENTAL', 'label': '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.', 'interventionNames': ['Drug: Leuprolide 7.5 mg / Degarelix 80 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Leuprolide 7.5 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.', 'interventionNames': ['Drug: Leuprolide 7.5 mg / Degarelix 160 mg']}], 'interventions': [{'name': 'Degarelix 80 mg / Degarelix 80 mg', 'type': 'DRUG', 'otherNames': ['Firmagon'], 'armGroupLabels': ['Degarelix 80 mg / Degarelix 80 mg']}, {'name': 'Degarelix 160 mg / Degarelix 160 mg', 'type': 'DRUG', 'otherNames': ['Firmagon'], 'armGroupLabels': ['Degarelix 160 mg / Degarelix 160 mg']}, {'name': 'Leuprolide 7.5 mg / Degarelix 80 mg', 'type': 'DRUG', 'otherNames': ['Firmagon', 'Lupron'], 'armGroupLabels': ['Leuprolide 7.5 mg / 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