Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-30 @ 12:51 AM
Study NCT ID:
NCT00295750
Status:
COMPLETED
Last Update Posted:
2012-12-19
First Post:
2006-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer
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': 'Ferring Pharmaceuticals', 'organization': 'Clinical Development Support'}, '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Degarelix 240/160 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.', 'otherNumAffected': 165, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'Degarelix 240/80 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.', 'otherNumAffected': 162, 'seriousNumAffected': 21}, {'id': 'EG002', 'title': 'Leuprolide 7.5 mg', 'description': 'Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.', 'otherNumAffected': 153, 'seriousNumAffected': 28}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 108, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 114, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 63, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 56, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 23, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 24, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 19, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 25, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Aspartate aminostransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 59, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 71, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 50, 'numAffected': 43}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myopericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Inguinal hernia, obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Large intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hepatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections 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0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240/160 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 240/80 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG002', 'title': 'Leuprolide 7.5 mg', 'description': 'Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '94.8', 'upperLimit': '99.4'}, {'value': '97.2', 'groupId': 'OG001', 'lowerLimit': '93.5', 'upperLimit': '98.8'}, {'value': '96.4', 'groupId': 'OG002', 'lowerLimit': '92.5', 'upperLimit': '98.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in cumulative probability', 'ciPctValue': '97.5', 'paramValue': '1.9', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '5.7', 'groupDescription': 'A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \\<=0.5 ng/mL from Day 28 to Day 364.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The non-inferiority limit was -10 percentage points.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in cumulative probability', 'ciPctValue': '97.5', 'paramValue': '0.9', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '5.0', 'groupDescription': 'A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \\<=0.5 ng/mL from Day 28 to Day 364.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The non-inferiority limit was -10 percentage points.'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Kaplan-Maier estimates of the cumulative probabilities of testosterone \\<=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone \\<=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240/160 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 240/80 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG002', 'title': 'Leuprolide 7.5 mg', 'description': 'Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '80.1', 'groupId': 'OG002', 'lowerLimit': '73.9', 'upperLimit': '85.4'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by \\>=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14).', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. If one or more of the testosterone values on Days 1, 3, 7 or 14 was missing, the last observation was carried forward.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240/160 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 240/80 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG002', 'title': 'Leuprolide 7.5 mg', 'description': 'Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 'lowerLimit': '91.7', 'upperLimit': '97.9'}, {'value': '96.1', 'groupId': 'OG001', 'lowerLimit': '92.5', 'upperLimit': '98.3'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '1.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '3 days', 'description': 'This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240/160 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 240/80 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG002', 'title': 'Leuprolide 7.5 mg', 'description': 'Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.'}], 'classes': [{'title': '<=-0.25 ng/mL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '>-0.25-0 ng/mL', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': '>0-0.25 ng/mL', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}]}, {'title': '>0.25-0.5 ng/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '>0.5 ng/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 252, Day 255, and Day 259', 'description': 'Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of \\<=-0.25, \\>-0.25-0, \\>0-0.25, \\>0.25-0.5 and \\>0.5 ng/mL from mean testosterone levels on Day 252.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population who had blood samples drawn on Day 252, Day 255, and Day 259.'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240/160 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 240/80 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG002', 'title': 'Leuprolide 7.5 mg', 'description': 'Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.'}], 'classes': [{'title': 'Day 14', 'categories': [{'measurements': [{'value': '-64.6', 'groupId': 'OG000', 'lowerLimit': '-77.8', 'upperLimit': '-40.8'}, {'value': '-63.4', 'groupId': 'OG001', 'lowerLimit': '-77.1', 'upperLimit': '-48.4'}, {'value': '-17.9', 'groupId': 'OG002', 'lowerLimit': '-35.5', 'upperLimit': '-5.2'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '-82.3', 'groupId': 'OG000', 'lowerLimit': '-91.4', 'upperLimit': '-68.3'}, {'value': '-84.9', 'groupId': 'OG001', 'lowerLimit': '-91.6', 'upperLimit': '-73.2'}, {'value': '-66.7', 'groupId': 'OG002', 'lowerLimit': '-81.3', 'upperLimit': '-47.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Percentage change from baseline to Day 14', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Percentage change from baseline to Day 14', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Percentage change from baseline to Day 28', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Percentage change from baseline to Day 28', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 14 and 28', 'description': 'Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Participants Grouped by Time to Prostate-specific Antigen Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240/160 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 240/80 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG002', 'title': 'Leuprolide 7.5 mg', 'description': 'Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.'}], 'classes': [{'title': 'Day 0-28 (patients at risk=193, 201, 194)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Day 0-56 (patients at risk=192, 197, 192)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Day 0-84 (patients at risk=190, 193, 190)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Day 0-112 (patients at risk=190, 189, 188)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Day 0-140 (patients at risk=187, 187, 182)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Day 0-168 (patients at risk=179, 185, 180)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Day 0-196 (patients at risk=173, 181, 175)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Day 0-224 (patients at risk=168, 175, 173)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Day 0-252 (patients at risk=165, 169, 168)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Day 0-280 (patients at risk=157, 165, 163)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Day 0-308 (patients at risk=153, 161, 156)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Day 0-336 (patients at risk=149, 156, 150)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Day 0-364 (patients at risk=149, 155, 148)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Cumulative probability', 'ciPctValue': '95', 'paramValue': '85.8', 'ciLowerLimit': '79.8', 'ciUpperLimit': '90.1', 'estimateComment': '95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Cumulative probability', 'ciPctValue': '95', 'paramValue': '91.1', 'ciLowerLimit': '85.9', 'ciUpperLimit': '94.5', 'estimateComment': '95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Cumulative probability', 'ciPctValue': '95', 'paramValue': '85.9', 'ciLowerLimit': '79.9', 'ciUpperLimit': '90.2', 'estimateComment': '95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of ≥50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Missing values were not imputed for this endpoint. Number in table represents the number of patients with prostate-specific antigen failure.'}, {'type': 'SECONDARY', 'title': 'Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240/160 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 240/80 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG002', 'title': 'Leuprolide 7.5 mg', 'description': 'Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.'}], 'classes': [{'title': 'Haematocrit (<=0.37 ratio)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}]}, {'title': 'Haemoglobin (<=115 g/L)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Serum Urea Nitrogen (>=10.7 mmol/L)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'Urine Protein (>=2 units from baseline)', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}]}, {'title': 'Urine Bacteria (0 at baseline and >0 on treatment)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Day 364', 'description': 'Criteria for lab values changes from baseline to the end of the study considered markedly abnormal were set for each lab test. If 20% of patients reached that value, the results were reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'The Mean Value of QTc Interval as Measured by Electrocardiogram', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240/160 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 240/80 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG002', 'title': 'Leuprolide 7.5 mg', 'description': 'Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.'}], 'classes': [{'title': 'Baseline Day 0 (n=202, 207, 201)', 'categories': [{'measurements': [{'value': '403', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '407', 'spread': '21.6', 'groupId': 'OG001'}, {'value': '404', 'spread': '19.4', 'groupId': 'OG002'}]}]}, {'title': 'Day 3 (n=195, 204, 197)', 'categories': [{'measurements': [{'value': '404', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '411', 'spread': '23.5', 'groupId': 'OG001'}, {'value': '405', 'spread': '23.0', 'groupId': 'OG002'}]}]}, {'title': 'End of study 12 months (n=202, 207, 201)', 'categories': [{'measurements': [{'value': '415', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '420', 'spread': '22.3', 'groupId': 'OG001'}, {'value': '419', 'spread': '23.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': "The QTc interval results are calculated with Fridericia's correction. QTc intervals are a standard evaluation of an electrocardiogram and help measure the risk of developing ventricular arrhythmias.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. End of Study values obtained at day 364 (+-7 days) for patients who completed. Patients who withdrew early had variable timeframes for the end of study value.'}, {'type': 'SECONDARY', 'title': 'Participants With Markedly Abnormal Change in Vital Signs and Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240/160 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 240/80 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'OG002', 'title': 'Leuprolide 7.5 mg', 'description': 'Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.'}], 'classes': [{'title': 'Systolic blood pressure <=90 and decrease >=20', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure >=180 and increase >=20', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure <=50 and decrease >=15', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure >=105 and increase >=15', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Heart rate <=50 and decrease >=15', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Heart rate >=120 and increase >=15', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Body weight decrease of >=7 percent', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Body weight increase of >=7 percent', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Vital signs and body weight included incidence of markedly abnormal changes from baseline to the end of the study in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes patients whose percent weight change from baseline fit the stated ranges.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Degarelix 240/160 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'FG001', 'title': 'Degarelix 240/80 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'FG002', 'title': 'Leuprolide 7.5 mg', 'description': 'Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'randomized', 'groupId': 'FG000', 'numSubjects': '206'}, {'comment': 'randomized', 'groupId': 'FG001', 'numSubjects': '210'}, {'comment': 'randomized', 'groupId': 'FG002', 'numSubjects': '204'}]}, {'type': 'Intent-to-treat (ITT) Population', 'achievements': [{'comment': 'randomized and exposed patients', 'groupId': 'FG000', 'numSubjects': '202'}, {'comment': 'randomized and exposed patients', 'groupId': 'FG001', 'numSubjects': '207'}, {'comment': 'randomized and exposed patients', 'groupId': 'FG002', 'numSubjects': '201'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '169'}, {'groupId': 'FG002', 'numSubjects': '172'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Taking prohibited therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Administrative errors', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Trial drug errors', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Personal reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Randomized but never received trial drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}, {'value': '610', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Degarelix 240/160 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'BG001', 'title': 'Degarelix 240/80 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.'}, {'id': 'BG002', 'title': 'Leuprolide 7.5 mg', 'description': 'Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}, {'value': '492', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Intent-to-treat (ITT) population.', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72', 'spread': '8.47', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '88'}, {'value': '72', 'spread': '8.12', 'groupId': 'BG001', 'lowerLimit': '51', 'upperLimit': '89'}, {'value': '74', 'spread': '8.77', 'groupId': 'BG002', 'lowerLimit': '52', 'upperLimit': '98'}, {'value': '73', 'spread': '8.45', 'groupId': 'BG003', 'lowerLimit': '50', 'upperLimit': '98'}]}]}], 'paramType': 'MEDIAN', 'description': 'ITT population.', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'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'}]}, {'title': 'Male', 'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}, {'value': '610', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ITT population.', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}, {'value': '511', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ITT population', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '257', 'groupId': 'BG003'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '353', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'ITT population', 'unitOfMeasure': 'participants'}, {'title': 'Curative Intent', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '178', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}, {'value': '532', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'ITT population. Curative intent refers to radical prostatectomy or radiotherapy.', 'unitOfMeasure': 'participants'}, {'title': 'Gleason Score', 'classes': [{'title': '2-4', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}]}, {'title': '5-6', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}]}]}, {'title': '7', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '181', 'groupId': 'BG003'}]}]}, {'title': '8-10', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': '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. Gleason scores were unavailable for 3 patients.', 'unitOfMeasure': 'participants'}, {'title': 'Stage of Prostate Cancer', 'classes': [{'title': 'Localized', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '191', 'groupId': 'BG003'}]}]}, {'title': 'Locally advanced', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '178', 'groupId': 'BG003'}]}]}, {'title': 'Metastatic', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}]}, {'title': 'Not classifiable', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'ITT population. Stage of prostate cancer was classified according to the Tumour, Nodule and Metastatic classification that is a cancer staging system that describes the extent of cancer. T describes the size of the tumor and whether it has invaded nearby tissue, N describes regional lymph nodes that are involved, and M describes distant metastasis', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'spread': '3.70', 'groupId': 'BG000'}, {'value': '26.7', 'spread': '4.21', 'groupId': 'BG001'}, {'value': '26.9', 'spread': '3.86', 'groupId': 'BG002'}, {'value': '26.8', 'spread': '3.93', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'ITT population', 'unitOfMeasure': 'kilogram per square meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum Prostate-specific Antigen Levels', 'classes': [{'categories': [{'measurements': [{'value': '19.9', 'groupId': 'BG000', 'lowerLimit': '8.2', 'upperLimit': '68'}, {'value': '19.8', 'groupId': 'BG001', 'lowerLimit': '9.4', 'upperLimit': '46'}, {'value': '19.0', 'groupId': 'BG002', 'lowerLimit': '8.7', 'upperLimit': '57'}, {'value': '19.0', 'groupId': 'BG003', 'lowerLimit': '8.7', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Serum Testosterone Levels', 'classes': [{'categories': [{'measurements': [{'value': '3.78', 'groupId': 'BG000', 'lowerLimit': '2.86', 'upperLimit': '5.05'}, {'value': '4.11', 'groupId': 'BG001', 'lowerLimit': '3.05', 'upperLimit': '5.32'}, {'value': '3.84', 'groupId': 'BG002', 'lowerLimit': '2.91', 'upperLimit': '5.01'}, {'value': '3.93', 'groupId': 'BG003', 'lowerLimit': '2.89', 'upperLimit': '5.10'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Time Since Prostate Cancer Diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '485', 'spread': '1109', 'groupId': 'BG000'}, {'value': '491', 'spread': '994', 'groupId': 'BG001'}, {'value': '497', 'spread': '1088', 'groupId': 'BG002'}, {'value': '491', 'spread': '1063', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'ITT population.', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '78.7', 'spread': '13.0', 'groupId': 'BG000'}, {'value': '79.8', 'spread': '14.9', 'groupId': 'BG001'}, {'value': '79.4', 'spread': '12.2', 'groupId': 'BG002'}, {'value': '79.3', 'spread': '13.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'ITT population', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 620}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-17', 'studyFirstSubmitDate': '2006-02-22', 'resultsFirstSubmitDate': '2009-01-05', 'studyFirstSubmitQcDate': '2006-02-22', 'lastUpdatePostDateStruct': {'date': '2012-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-03-13', 'studyFirstPostDateStruct': {'date': '2006-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364', 'timeFrame': '12 months', 'description': 'Kaplan-Maier estimates of the cumulative probabilities of testosterone \\<=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone \\<=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment', 'timeFrame': '2 weeks', 'description': 'A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by \\>=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14).'}, {'measure': 'Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3', 'timeFrame': '3 days', 'description': 'This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.'}, {'measure': 'Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252', 'timeFrame': 'Day 252, Day 255, and Day 259', 'description': 'Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of \\<=-0.25, \\>-0.25-0, \\>0-0.25, \\>0.25-0.5 and \\>0.5 ng/mL from mean testosterone levels on Day 252.'}, {'measure': 'Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28', 'timeFrame': 'Days 14 and 28', 'description': 'Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression.'}, {'measure': 'Participants Grouped by Time to Prostate-specific Antigen Failure', 'timeFrame': '12 months', 'description': 'The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of ≥50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted.'}, {'measure': 'Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)', 'timeFrame': 'Baseline to Day 364', 'description': 'Criteria for lab values changes from baseline to the end of the study considered markedly abnormal were set for each lab test. If 20% of patients reached that value, the results were reported.'}, {'measure': 'The Mean Value of QTc Interval as Measured by Electrocardiogram', 'timeFrame': '12 months', 'description': "The QTc interval results are calculated with Fridericia's correction. QTc intervals are a standard evaluation of an electrocardiogram and help measure the risk of developing ventricular arrhythmias."}, {'measure': 'Participants With Markedly Abnormal Change in Vital Signs and Body Weight', 'timeFrame': '12 months', 'description': 'Vital signs and body weight included incidence of markedly abnormal changes from baseline to the end of the study in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prostate Cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '19035858', 'type': 'RESULT', 'citation': 'Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schroder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. doi: 10.1111/j.1464-410X.2008.08183.x.'}, {'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': 'The study was a three-arm, active-control, multi-centre, parallel group study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Patients, aged 18 years or over, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.\n* Baseline testosterone \\>1.5 ng/mL.\n* Life expectancy of at least 12 months.'}, 'identificationModule': {'nctId': 'NCT00295750', 'briefTitle': 'The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'An Open-label, Multi-Centre, Randomized, Parallel-group Study, Investigating the Efficacy and Safety of Degarelix One Month Dosing Regimens; 160 mg (40 mg/ml) and 80 mg (20mg/ml), in Comparison to LUPRON DEPOT® 7.5 mg in Patients With Prostate Cancer Requiring Androgen Ablation Therapy', 'orgStudyIdInfo': {'id': 'FE200486 CS21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'degarelix 240/160 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.', 'interventionNames': ['Drug: Degarelix']}, {'type': 'EXPERIMENTAL', 'label': 'degarelix 240/80 mg', 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.', 'interventionNames': ['Drug: Degarelix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Leuprolide 7.5 mg', 'description': 'Leuprolide (Lupron Depot) 7.5 mg IM (in the muscle) every 28 days starting at day 0.', 'interventionNames': ['Drug: Leuprolide 7.5 mg']}], 'interventions': [{'name': 'Degarelix', 'type': 'DRUG', 'otherNames': ['FE200486'], 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days.', 'armGroupLabels': ['degarelix 240/160 mg']}, {'name': 'Degarelix', 'type': 'DRUG', 'otherNames': ['FE 200486'], 'description': 'Initial dose of 240 mg SC (by injection under the skin) on day 0. 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