Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 7:39 AM
Study NCT ID:
NCT00928434
Status:
COMPLETED
Last Update Posted:
2016-12-13
First Post:
2009-06-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Degarelix in Patients With 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': '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': '15 months', 'description': 'Information related to AEs were collected throughout the trial from the time the subject signed the informed consent form till the end of the follow-up period.', 'eventGroups': [{'id': 'EG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.', 'otherNumAtRisk': 175, 'otherNumAffected': 159, 'seriousNumAtRisk': 175, 'seriousNumAffected': 26}, {'id': 'EG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).', 'otherNumAtRisk': 50, 'otherNumAffected': 47, 'seriousNumAtRisk': 50, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).", 'otherNumAtRisk': 178, 'otherNumAffected': 158, 'seriousNumAtRisk': 178, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 284, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 150, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 32, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 41, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 124, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 56, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 40, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection site oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 15, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 21, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 13, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 19, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasophayrngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 27, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 18, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 91, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 113, 'numAffected': 110}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Peptic ulcer hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutropenic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bile duct cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lung squamous cell carcinoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neuroendocrine carcinoma of the skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': "Dementia alzheimer's type", 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pelvic venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Peripheral ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Subclavian steal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Venous insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'Total Continuous', 'description': 'This is the combination of degarelix continuous and leuprolide continuous treatment arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.3', 'upperLimit': '100'}, {'value': '98.4', 'groupId': 'OG001', 'lowerLimit': '95.5', 'upperLimit': '99.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.57', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '3.33', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was defined as a lower bound (LCL) of the 95% confidence interval for the difference between the intermittent and pooled continuous treatments, CADT, (intermittent - continuous) of greater than -12.5%.'}], 'paramType': 'NUMBER', 'timeFrame': 'At 14 month', 'description': 'Percentage of patients with serum PSA levels ≤4.0 ng/mL at 14 month was presented.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Serum PSA Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'OG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."}], 'classes': [{'title': 'Phase A, Visit 1 (Day 0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': 'NA', 'comment': 'One patient erroneously received medication prior to this visit. Thus, the value obtained on this visit was considered as first post-baseline value for this patient and is reported. There was no SD.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 2 (Month 1)', 'categories': [{'measurements': [{'value': '-6.39', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '-14.3', 'spread': '34.8', 'groupId': 'OG001'}, {'value': '-6.38', 'spread': '13.2', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 3 (Month 2)', 'categories': [{'measurements': [{'value': '-6.94', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '-14.8', 'spread': '34.9', 'groupId': 'OG001'}, {'value': '-8.12', 'spread': '15.4', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 4 (Month 3)', 'categories': [{'measurements': [{'value': '-7.07', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '-15', 'spread': '35', 'groupId': 'OG001'}, {'value': '-8.44', 'spread': '15.7', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 5 (Month 4)', 'categories': [{'measurements': [{'value': '-7.16', 'spread': '11', 'groupId': 'OG000'}, {'value': '-15.1', 'spread': '35.2', 'groupId': 'OG001'}, {'value': '-8.51', 'spread': '15.8', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 6 (Month 5)', 'categories': [{'measurements': [{'value': '-7.19', 'spread': '11', 'groupId': 'OG000'}, {'value': '-15.1', 'spread': '35.2', 'groupId': 'OG001'}, {'value': '-8.59', 'spread': '15.9', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 7 (Month 6)', 'categories': [{'measurements': [{'value': '-7.21', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '-15.1', 'spread': '35.2', 'groupId': 'OG001'}, {'value': '-8.64', 'spread': '15.9', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 8 (Month 7)', 'categories': [{'measurements': [{'value': '-7.24', 'spread': '11', 'groupId': 'OG000'}, {'value': '-15.1', 'spread': '35.2', 'groupId': 'OG001'}, {'value': '-8.64', 'spread': '15.9', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 9 (Month 8)', 'categories': [{'measurements': [{'value': '-7.25', 'spread': '11', 'groupId': 'OG000'}, {'value': '-15', 'spread': '34.7', 'groupId': 'OG001'}, {'value': '-8.64', 'spread': '15.9', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 10 (Month 9)', 'categories': [{'measurements': [{'value': '-7.18', 'spread': '11', 'groupId': 'OG000'}, {'value': '-15', 'spread': '34.7', 'groupId': 'OG001'}, {'value': '-8.64', 'spread': '15.9', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 11 (Month 10)', 'categories': [{'measurements': [{'value': '-7.07', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '-14.9', 'spread': '34.3', 'groupId': 'OG001'}, {'value': '-8.63', 'spread': '15.9', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 12 (Month 11)', 'categories': [{'measurements': [{'value': '-6.96', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '-14.9', 'spread': '33.9', 'groupId': 'OG001'}, {'value': '-8.64', 'spread': '15.9', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 13 (Month 12)', 'categories': [{'measurements': [{'value': '-6.81', 'spread': '11', 'groupId': 'OG000'}, {'value': '-14.8', 'spread': '33.9', 'groupId': 'OG001'}, {'value': '-8.64', 'spread': '15.9', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 14 (Month 13)', 'categories': [{'measurements': [{'value': '-6.79', 'spread': '11', 'groupId': 'OG000'}, {'value': '-14.8', 'spread': '33.9', 'groupId': 'OG001'}, {'value': '-8.59', 'spread': '16', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 15 (Month 14)', 'categories': [{'measurements': [{'value': '-6.74', 'spread': '11', 'groupId': 'OG000'}, {'value': '-14.8', 'spread': '33.9', 'groupId': 'OG001'}, {'value': '-8.6', 'spread': '15.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Phase A Visit 1-8 and Phase B Visit 9-15.', 'description': 'Absolute change from Baseline in serum PSA levels during the study period was measured.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Serum PSA Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'OG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."}], 'classes': [{'title': 'Phase A, Visit 1 (Day 0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.', 'groupId': 'OG000'}, {'value': '-39.6', 'spread': 'NA', 'comment': 'One patient erroneously received medication prior to this visit. Thus, the value obtained on this visit was considered as first post-baseline value for this patient and is reported. There was no SD.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 2 (Month 1)', 'categories': [{'measurements': [{'value': '-80.8', 'spread': '24.4', 'groupId': 'OG000'}, {'value': '-84.5', 'spread': '11.8', 'groupId': 'OG001'}, {'value': '-62.8', 'spread': '31.2', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 3 (Month 2)', 'categories': [{'measurements': [{'value': '-90.4', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '-92.4', 'spread': '8.23', 'groupId': 'OG001'}, {'value': '-87.3', 'spread': '12.3', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 4 (Month 3)', 'categories': [{'measurements': [{'value': '-92.8', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '-94.5', 'spread': '7.37', 'groupId': 'OG001'}, {'value': '-92.3', 'spread': '7.67', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 5 (Month 4)', 'categories': [{'measurements': [{'value': '-94.1', 'spread': '8.45', 'groupId': 'OG000'}, {'value': '-95.5', 'spread': '7.05', 'groupId': 'OG001'}, {'value': '-93.4', 'spread': '9.39', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 6 (Month 5)', 'categories': [{'measurements': [{'value': '-94.2', 'spread': '9.31', 'groupId': 'OG000'}, {'value': '-95.7', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '-94.5', 'spread': '7.52', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 7 (Month 6)', 'categories': [{'measurements': [{'value': '-94.8', 'spread': '8.34', 'groupId': 'OG000'}, {'value': '-95.8', 'spread': '8.64', 'groupId': 'OG001'}, {'value': '-95.3', 'spread': '7.23', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 8 (Month 7)', 'categories': [{'measurements': [{'value': '-95.4', 'spread': '7.13', 'groupId': 'OG000'}, {'value': '-95.4', 'spread': '10.8', 'groupId': 'OG001'}, {'value': '-95.5', 'spread': '7.62', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 9 (Month 8)', 'categories': [{'measurements': [{'value': '-95.7', 'spread': '6.97', 'groupId': 'OG000'}, {'value': '-95.5', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '-95.2', 'spread': '12.3', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 10 (Month 9)', 'categories': [{'measurements': [{'value': '-93.6', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '-95.6', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '-94.3', 'spread': '23.2', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 11 (Month 10)', 'categories': [{'measurements': [{'value': '-91.9', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '-95.7', 'spread': '9.46', 'groupId': 'OG001'}, {'value': '-93.1', 'spread': '24.9', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 12 (Month 11)', 'categories': [{'measurements': [{'value': '-88', 'spread': '22.7', 'groupId': 'OG000'}, {'value': '-95.1', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '-94.4', 'spread': '23.5', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 13 (Month 12)', 'categories': [{'measurements': [{'value': '-84.2', 'spread': '24.9', 'groupId': 'OG000'}, {'value': '-95.1', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '-94.5', 'spread': '23.5', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 14 (Month 13)', 'categories': [{'measurements': [{'value': '-82.8', 'spread': '24.9', 'groupId': 'OG000'}, {'value': '-95.1', 'spread': '10.4', 'groupId': 'OG001'}, {'value': '-93.1', 'spread': '25.9', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 15 (Month 14)', 'categories': [{'measurements': [{'value': '-80.8', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '-94.4', 'spread': '12.9', 'groupId': 'OG001'}, {'value': '-93.7', 'spread': '25.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Phase A Visit 1-8 and Phase B Visit 9-15.', 'description': 'Percent change from Baseline in serum PSA levels during the study period was measured.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B analysis set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'OG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each)."}, {'id': 'OG003', 'title': 'Total Continuous', 'description': 'This is the combination of degarelix continuous and leuprolide continuous treatment arms.'}], 'classes': [{'title': 'Phase A, Month 3', 'categories': [{'measurements': [{'value': '-1.47', 'groupId': 'OG000', 'lowerLimit': '-1.99', 'upperLimit': '-0.94'}, {'value': '-1.63', 'groupId': 'OG001', 'lowerLimit': '-2.59', 'upperLimit': '-0.67'}, {'value': '-1.41', 'groupId': 'OG002', 'lowerLimit': '-1.92', 'upperLimit': '-0.90'}, {'value': '-1.46', 'groupId': 'OG003', 'lowerLimit': '-1.90', 'upperLimit': '-1.01'}]}]}, {'title': 'Phase A, Month 7', 'categories': [{'measurements': [{'value': '-1.41', 'groupId': 'OG000', 'lowerLimit': '-1.93', 'upperLimit': '-0.88'}, {'value': '-1.48', 'groupId': 'OG001', 'lowerLimit': '-2.43', 'upperLimit': '-0.52'}, {'value': '-1.67', 'groupId': 'OG002', 'lowerLimit': '-2.17', 'upperLimit': '-1.17'}, {'value': '-1.63', 'groupId': 'OG003', 'lowerLimit': '-2.07', 'upperLimit': '-1.18'}]}]}, {'title': 'Phase B, Month 8', 'categories': [{'measurements': [{'value': '-0.96', 'groupId': 'OG000', 'lowerLimit': '-1.46', 'upperLimit': '-0.46'}, {'value': '-1.92', 'groupId': 'OG001', 'lowerLimit': '-2.83', 'upperLimit': '-1.01'}, {'value': '-1.74', 'groupId': 'OG002', 'lowerLimit': '-2.22', 'upperLimit': '-1.27'}, {'value': '-1.78', 'groupId': 'OG003', 'lowerLimit': '-2.20', 'upperLimit': '-1.36'}]}]}, {'title': 'Phase B, Month 9', 'categories': [{'measurements': [{'value': '-1.24', 'groupId': 'OG000', 'lowerLimit': '-1.80', 'upperLimit': '-0.68'}, {'value': '-1.85', 'groupId': 'OG001', 'lowerLimit': '-2.87', 'upperLimit': '-0.82'}, {'value': '-1.77', 'groupId': 'OG002', 'lowerLimit': '-2.31', 'upperLimit': '-1.24'}, {'value': '-1.79', 'groupId': 'OG003', 'lowerLimit': '-2.26', 'upperLimit': '-1.32'}]}]}, {'title': 'Phase B, Month 10', 'categories': [{'measurements': [{'value': '-1.05', 'groupId': 'OG000', 'lowerLimit': '-1.63', 'upperLimit': '-0.48'}, {'value': '-2.08', 'groupId': 'OG001', 'lowerLimit': '-3.13', 'upperLimit': '-1.03'}, {'value': '-1.68', 'groupId': 'OG002', 'lowerLimit': '-2.23', 'upperLimit': '-1.13'}, {'value': '-1.76', 'groupId': 'OG003', 'lowerLimit': '-2.25', 'upperLimit': '-1.28'}]}]}, {'title': 'Phase B, Month 11', 'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000', 'lowerLimit': '-1.56', 'upperLimit': '-0.44'}, {'value': '-1.77', 'groupId': 'OG001', 'lowerLimit': '-2.79', 'upperLimit': '-0.75'}, {'value': '-1.53', 'groupId': 'OG002', 'lowerLimit': '-2.07', 'upperLimit': '-1.00'}, {'value': '-1.58', 'groupId': 'OG003', 'lowerLimit': '-2.05', 'upperLimit': '-1.11'}]}]}, {'title': 'Phase B, Month 12', 'categories': [{'measurements': [{'value': '-0.91', 'groupId': 'OG000', 'lowerLimit': '-1.44', 'upperLimit': '-0.38'}, {'value': '-1.62', 'groupId': 'OG001', 'lowerLimit': '-2.59', 'upperLimit': '-0.66'}, {'value': '-1.32', 'groupId': 'OG002', 'lowerLimit': '-1.83', 'upperLimit': '-0.82'}, {'value': '-1.39', 'groupId': 'OG003', 'lowerLimit': '-1.83', 'upperLimit': '-0.94'}]}]}, {'title': 'Phase B, Month 13', 'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000', 'lowerLimit': '-1.57', 'upperLimit': '-0.43'}, {'value': '-2.10', 'groupId': 'OG001', 'lowerLimit': '-3.14', 'upperLimit': '-1.06'}, {'value': '-1.40', 'groupId': 'OG002', 'lowerLimit': '-1.95', 'upperLimit': '-0.86'}, {'value': '-1.55', 'groupId': 'OG003', 'lowerLimit': '-2.04', 'upperLimit': '-1.07'}]}]}, {'title': 'Phase B, Month 14', 'categories': [{'measurements': [{'value': '-1.04', 'groupId': 'OG000', 'lowerLimit': '-1.62', 'upperLimit': '-0.47'}, {'value': '-1.90', 'groupId': 'OG001', 'lowerLimit': '-2.95', 'upperLimit': '-0.85'}, {'value': '-1.45', 'groupId': 'OG002', 'lowerLimit': '-2.00', 'upperLimit': '-0.91'}, {'value': '-1.55', 'groupId': 'OG003', 'lowerLimit': '-2.03', 'upperLimit': '-1.06'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During 14 months', 'description': 'The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.\n\nPhysical well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the physical well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'DC (Degarelix Continuous)', 'description': 'administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'OG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each)."}, {'id': 'OG003', 'title': 'Total Continuous', 'description': 'This is the combination of degarelix continuous and leuprolide continuous treatment arms.'}], 'classes': [{'title': 'Phase A, Month 3', 'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '1.20'}, {'value': '1.31', 'groupId': 'OG001', 'lowerLimit': '0.37', 'upperLimit': '2.24'}, {'value': '0.76', 'groupId': 'OG002', 'lowerLimit': '0.27', 'upperLimit': '1.24'}, {'value': '0.88', 'groupId': 'OG003', 'lowerLimit': '0.45', 'upperLimit': '1.30'}]}]}, {'title': 'Phase A, Month 7', 'categories': [{'measurements': [{'value': '0.67', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '1.18'}, {'value': '0.57', 'groupId': 'OG001', 'lowerLimit': '-0.37', 'upperLimit': '1.51'}, {'value': '0.90', 'groupId': 'OG002', 'lowerLimit': '0.42', 'upperLimit': '1.39'}, {'value': '0.83', 'groupId': 'OG003', 'lowerLimit': '0.40', 'upperLimit': '1.26'}]}]}, {'title': 'Phase B, Month 8', 'categories': [{'measurements': [{'value': '0.65', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '1.14'}, {'value': '0.95', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '1.86'}, {'value': '1.11', 'groupId': 'OG002', 'lowerLimit': '0.65', 'upperLimit': '1.58'}, {'value': '1.08', 'groupId': 'OG003', 'lowerLimit': '0.67', 'upperLimit': '1.49'}]}]}, {'title': 'Phase B, Month 9', 'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.27', 'upperLimit': '1.24'}, {'value': '1.11', 'groupId': 'OG001', 'lowerLimit': '0.22', 'upperLimit': '2.01'}, {'value': '1.16', 'groupId': 'OG002', 'lowerLimit': '0.70', 'upperLimit': '1.62'}, {'value': '1.15', 'groupId': 'OG003', 'lowerLimit': '0.74', 'upperLimit': '1.56'}]}]}, {'title': 'Phase B, Month 10', 'categories': [{'measurements': [{'value': '1.09', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '1.60'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.94', 'upperLimit': '0.95'}, {'value': '0.98', 'groupId': 'OG002', 'lowerLimit': '0.49', 'upperLimit': '1.46'}, {'value': '0.77', 'groupId': 'OG003', 'lowerLimit': '0.34', 'upperLimit': '1.20'}]}]}, {'title': 'Phase B, Month 11', 'categories': [{'measurements': [{'value': '0.82', 'groupId': 'OG000', 'lowerLimit': '0.34', 'upperLimit': '1.30'}, {'value': '0.94', 'groupId': 'OG001', 'lowerLimit': '0.06', 'upperLimit': '1.83'}, {'value': '1.05', 'groupId': 'OG002', 'lowerLimit': '0.59', 'upperLimit': '1.50'}, {'value': '1.03', 'groupId': 'OG003', 'lowerLimit': '0.62', 'upperLimit': '1.43'}]}]}, {'title': 'Phase B, Month 12', 'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '1.50'}, {'value': '1.07', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '2.02'}, {'value': '1.23', 'groupId': 'OG002', 'lowerLimit': '0.74', 'upperLimit': '1.72'}, {'value': '1.20', 'groupId': 'OG003', 'lowerLimit': '0.76', 'upperLimit': '1.63'}]}]}, {'title': 'Phase B, Month 13', 'categories': [{'measurements': [{'value': '0.74', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '1.26'}, {'value': '0.52', 'groupId': 'OG001', 'lowerLimit': '-0.43', 'upperLimit': '1.48'}, {'value': '1.14', 'groupId': 'OG002', 'lowerLimit': '0.64', 'upperLimit': '1.63'}, {'value': '1.01', 'groupId': 'OG003', 'lowerLimit': '0.57', 'upperLimit': '1.45'}]}]}, {'title': 'Phase B, Month 14', 'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000', 'lowerLimit': '-0.13', 'upperLimit': '0.93'}, {'value': '0.86', 'groupId': 'OG001', 'lowerLimit': '-0.11', 'upperLimit': '1.83'}, {'value': '1.12', 'groupId': 'OG002', 'lowerLimit': '0.62', 'upperLimit': '1.62'}, {'value': '1.06', 'groupId': 'OG003', 'lowerLimit': '0.62', 'upperLimit': '1.51'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During 14 months', 'description': 'The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.\n\nEmotional well-being consist of 6 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the emotional well-being sub scale ranges from 0 to 24. Higher scores represent better QoL.Higher scores represent better QoL.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'OG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each)."}, {'id': 'OG003', 'title': 'Total Continuous', 'description': 'This is the combination of degarelix continuous and leuprolide continuous treatment arms.'}], 'classes': [{'title': 'Phase A, Month 3', 'categories': [{'measurements': [{'value': '-0.18', 'groupId': 'OG000', 'lowerLimit': '-0.96', 'upperLimit': '0.60'}, {'value': '-0.06', 'groupId': 'OG001', 'lowerLimit': '-1.48', 'upperLimit': '1.35'}, {'value': '-0.36', 'groupId': 'OG002', 'lowerLimit': '-1.11', 'upperLimit': '0.38'}, {'value': '-0.30', 'groupId': 'OG003', 'lowerLimit': '-0.95', 'upperLimit': '0.36'}]}]}, {'title': 'Phase A, Month 7', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.79', 'upperLimit': '0.79'}, {'value': '-0.30', 'groupId': 'OG001', 'lowerLimit': '-1.75', 'upperLimit': '1.14'}, {'value': '-0.46', 'groupId': 'OG002', 'lowerLimit': '-1.21', 'upperLimit': '0.29'}, {'value': '-0.43', 'groupId': 'OG003', 'lowerLimit': '-1.09', 'upperLimit': '0.24'}]}]}, {'title': 'Phase B, Month 8', 'categories': [{'measurements': [{'value': '-0.33', 'groupId': 'OG000', 'lowerLimit': '-1.06', 'upperLimit': '0.39'}, {'value': '-0.52', 'groupId': 'OG001', 'lowerLimit': '-1.84', 'upperLimit': '0.80'}, {'value': '-0.41', 'groupId': 'OG002', 'lowerLimit': '-1.10', 'upperLimit': '0.28'}, {'value': '-0.43', 'groupId': 'OG003', 'lowerLimit': '-1.04', 'upperLimit': '0.18'}]}]}, {'title': 'Phase B, Month 9', 'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.80', 'upperLimit': '0.77'}, {'value': '-0.95', 'groupId': 'OG001', 'lowerLimit': '-2.37', 'upperLimit': '0.47'}, {'value': '-1.10', 'groupId': 'OG002', 'lowerLimit': '-1.84', 'upperLimit': '-0.36'}, {'value': '-1.07', 'groupId': 'OG003', 'lowerLimit': '-1.72', 'upperLimit': '-0.41'}]}]}, {'title': 'Phase B, Month 10', 'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000', 'lowerLimit': '-0.42', 'upperLimit': '1.14'}, {'value': '-1.00', 'groupId': 'OG001', 'lowerLimit': '-2.42', 'upperLimit': '0.42'}, {'value': '-1.15', 'groupId': 'OG002', 'lowerLimit': '-1.89', 'upperLimit': '-0.41'}, {'value': '-1.12', 'groupId': 'OG003', 'lowerLimit': '-1.77', 'upperLimit': '-0.46'}]}]}, {'title': 'Phase B, Month 11', 'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000', 'lowerLimit': '-0.63', 'upperLimit': '1.02'}, {'value': '-1.09', 'groupId': 'OG001', 'lowerLimit': '-2.59', 'upperLimit': '0.42'}, {'value': '-0.83', 'groupId': 'OG002', 'lowerLimit': '-1.61', 'upperLimit': '-0.05'}, {'value': '-0.88', 'groupId': 'OG003', 'lowerLimit': '-1.58', 'upperLimit': '-0.19'}]}]}, {'title': 'Phase B, Month 12', 'categories': [{'measurements': [{'value': '-0.16', 'groupId': 'OG000', 'lowerLimit': '-0.94', 'upperLimit': '0.63'}, {'value': '-1.34', 'groupId': 'OG001', 'lowerLimit': '-2.78', 'upperLimit': '0.09'}, {'value': '-0.85', 'groupId': 'OG002', 'lowerLimit': '-1.59', 'upperLimit': '-0.10'}, {'value': '-0.95', 'groupId': 'OG003', 'lowerLimit': '-1.61', 'upperLimit': '-0.29'}]}]}, {'title': 'Phase B, Month 13', 'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.79', 'upperLimit': '0.74'}, {'value': '-1.35', 'groupId': 'OG001', 'lowerLimit': '-2.74', 'upperLimit': '0.03'}, {'value': '-0.72', 'groupId': 'OG002', 'lowerLimit': '-1.44', 'upperLimit': '0.00'}, {'value': '-0.85', 'groupId': 'OG003', 'lowerLimit': '-1.49', 'upperLimit': '-0.21'}]}]}, {'title': 'Phase B, Month 14', 'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000', 'lowerLimit': '-0.44', 'upperLimit': '1.01'}, {'value': '-0.68', 'groupId': 'OG001', 'lowerLimit': '-2.00', 'upperLimit': '0.64'}, {'value': '-0.55', 'groupId': 'OG002', 'lowerLimit': '-1.24', 'upperLimit': '0.14'}, {'value': '-0.58', 'groupId': 'OG003', 'lowerLimit': '-1.19', 'upperLimit': '0.03'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During 14 months', 'description': 'The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.\n\nSocial well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the social well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'OG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."}, {'id': 'OG003', 'title': 'Total Continuous', 'description': 'This is the combination of degarelix continuous and leuprolide continuous treatment arms.'}], 'classes': [{'title': 'Phase A, Month 3', 'categories': [{'measurements': [{'value': '-0.96', 'groupId': 'OG000', 'lowerLimit': '-1.70', 'upperLimit': '-0.23'}, {'value': '-0.88', 'groupId': 'OG001', 'lowerLimit': '-2.23', 'upperLimit': '0.47'}, {'value': '-0.29', 'groupId': 'OG002', 'lowerLimit': '-0.99', 'upperLimit': '0.41'}, {'value': '-0.42', 'groupId': 'OG003', 'lowerLimit': '-1.04', 'upperLimit': '0.21'}]}]}, {'title': 'Phase A, Month 7', 'categories': [{'measurements': [{'value': '-1.41', 'groupId': 'OG000', 'lowerLimit': '-2.25', 'upperLimit': '-0.58'}, {'value': '-0.78', 'groupId': 'OG001', 'lowerLimit': '-2.31', 'upperLimit': '0.76'}, {'value': '-1.24', 'groupId': 'OG002', 'lowerLimit': '-2.03', 'upperLimit': '-0.45'}, {'value': '-1.15', 'groupId': 'OG003', 'lowerLimit': '-1.85', 'upperLimit': '-0.44'}]}]}, {'title': 'Phase B, Month 8', 'categories': [{'measurements': [{'value': '-1.18', 'groupId': 'OG000', 'lowerLimit': '-1.90', 'upperLimit': '-0.45'}, {'value': '-1.08', 'groupId': 'OG001', 'lowerLimit': '-2.41', 'upperLimit': '0.26'}, {'value': '-0.73', 'groupId': 'OG002', 'lowerLimit': '-1.42', 'upperLimit': '-0.04'}, {'value': '-0.80', 'groupId': 'OG003', 'lowerLimit': '-1.41', 'upperLimit': '-0.19'}]}]}, {'title': 'Phase B, Month 9', 'categories': [{'measurements': [{'value': '-1.14', 'groupId': 'OG000', 'lowerLimit': '-1.94', 'upperLimit': '-0.34'}, {'value': '-1.07', 'groupId': 'OG001', 'lowerLimit': '-2.53', 'upperLimit': '0.40'}, {'value': '-1.23', 'groupId': 'OG002', 'lowerLimit': '-1.99', 'upperLimit': '-0.47'}, {'value': '-1.20', 'groupId': 'OG003', 'lowerLimit': '-1.87', 'upperLimit': '-0.52'}]}]}, {'title': 'Phase B, Month 10', 'categories': [{'measurements': [{'value': '-1.35', 'groupId': 'OG000', 'lowerLimit': '-2.15', 'upperLimit': '-0.54'}, {'value': '-0.89', 'groupId': 'OG001', 'lowerLimit': '-2.36', 'upperLimit': '0.58'}, {'value': '-1.42', 'groupId': 'OG002', 'lowerLimit': '-2.18', 'upperLimit': '-0.66'}, {'value': '-1.31', 'groupId': 'OG003', 'lowerLimit': '-1.98', 'upperLimit': '-0.63'}]}]}, {'title': 'Phase B, Month 11', 'categories': [{'measurements': [{'value': '-1.25', 'groupId': 'OG000', 'lowerLimit': '-2.08', 'upperLimit': '-0.43'}, {'value': '-0.80', 'groupId': 'OG001', 'lowerLimit': '-2.32', 'upperLimit': '0.72'}, {'value': '-1.24', 'groupId': 'OG002', 'lowerLimit': '-2.02', 'upperLimit': '-0.46'}, {'value': '-1.15', 'groupId': 'OG003', 'lowerLimit': '-1.84', 'upperLimit': '-0.45'}]}]}, {'title': 'Phase B, Month 12', 'categories': [{'measurements': [{'value': '-0.92', 'groupId': 'OG000', 'lowerLimit': '-1.70', 'upperLimit': '-0.15'}, {'value': '-1.49', 'groupId': 'OG001', 'lowerLimit': '-2.91', 'upperLimit': '-0.07'}, {'value': '-0.73', 'groupId': 'OG002', 'lowerLimit': '-1.46', 'upperLimit': '0.00'}, {'value': '-0.89', 'groupId': 'OG003', 'lowerLimit': '-1.54', 'upperLimit': '-0.24'}]}]}, {'title': 'Phase B, Month 13', 'categories': [{'measurements': [{'value': '-1.49', 'groupId': 'OG000', 'lowerLimit': '-2.32', 'upperLimit': '-0.66'}, {'value': '-2.22', 'groupId': 'OG001', 'lowerLimit': '-3.75', 'upperLimit': '-0.69'}, {'value': '-0.96', 'groupId': 'OG002', 'lowerLimit': '-1.75', 'upperLimit': '-0.17'}, {'value': '-1.22', 'groupId': 'OG003', 'lowerLimit': '-1.93', 'upperLimit': '-0.52'}]}]}, {'title': 'Phase B, Month 14', 'categories': [{'measurements': [{'value': '-1.02', 'groupId': 'OG000', 'lowerLimit': '-1.78', 'upperLimit': '-0.26'}, {'value': '-1.95', 'groupId': 'OG001', 'lowerLimit': '-3.35', 'upperLimit': '-0.55'}, {'value': '-0.84', 'groupId': 'OG002', 'lowerLimit': '-1.56', 'upperLimit': '-0.12'}, {'value': '-1.07', 'groupId': 'OG003', 'lowerLimit': '-1.71', 'upperLimit': '-0.43'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During 14 months', 'description': 'The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.\n\nFunctional well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the functional well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'OG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."}, {'id': 'OG003', 'title': 'Total Continuous', 'description': 'This is the combination of degarelix continuous and leuprolide continuous treatment arms.'}], 'classes': [{'title': 'Phase A, Month 3', 'categories': [{'measurements': [{'value': '-1.14', 'groupId': 'OG000', 'lowerLimit': '-1.96', 'upperLimit': '-0.32'}, {'value': '-0.92', 'groupId': 'OG001', 'lowerLimit': '-2.42', 'upperLimit': '0.57'}, {'value': '-0.51', 'groupId': 'OG002', 'lowerLimit': '-1.30', 'upperLimit': '0.27'}, {'value': '-0.60', 'groupId': 'OG003', 'lowerLimit': '-1.29', 'upperLimit': '0.09'}]}]}, {'title': 'Phase A, Month 7', 'categories': [{'measurements': [{'value': '-0.89', 'groupId': 'OG000', 'lowerLimit': '-1.71', 'upperLimit': '-0.07'}, {'value': '-1.34', 'groupId': 'OG001', 'lowerLimit': '-2.83', 'upperLimit': '0.16'}, {'value': '-1.03', 'groupId': 'OG002', 'lowerLimit': '-1.81', 'upperLimit': '-0.25'}, {'value': '-1.10', 'groupId': 'OG003', 'lowerLimit': '-1.79', 'upperLimit': '-0.40'}]}]}, {'title': 'Phase B, Month 8', 'categories': [{'measurements': [{'value': '-1.29', 'groupId': 'OG000', 'lowerLimit': '-2.10', 'upperLimit': '-0.48'}, {'value': '-1.03', 'groupId': 'OG001', 'lowerLimit': '-2.50', 'upperLimit': '0.45'}, {'value': '-0.63', 'groupId': 'OG002', 'lowerLimit': '-1.40', 'upperLimit': '0.14'}, {'value': '-0.72', 'groupId': 'OG003', 'lowerLimit': '-1.40', 'upperLimit': '-0.03'}]}]}, {'title': 'Phase B, Month 9', 'categories': [{'measurements': [{'value': '-0.97', 'groupId': 'OG000', 'lowerLimit': '-1.83', 'upperLimit': '-0.11'}, {'value': '-1.64', 'groupId': 'OG001', 'lowerLimit': '-3.20', 'upperLimit': '-0.07'}, {'value': '-0.90', 'groupId': 'OG002', 'lowerLimit': '-1.72', 'upperLimit': '-0.08'}, {'value': '-1.06', 'groupId': 'OG003', 'lowerLimit': '-1.79', 'upperLimit': '-0.34'}]}]}, {'title': 'Phase B, Month 10', 'categories': [{'measurements': [{'value': '-0.86', 'groupId': 'OG000', 'lowerLimit': '-1.73', 'upperLimit': '0.01'}, {'value': '-0.80', 'groupId': 'OG001', 'lowerLimit': '-2.39', 'upperLimit': '0.78'}, {'value': '-0.70', 'groupId': 'OG002', 'lowerLimit': '-1.52', 'upperLimit': '0.13'}, {'value': '-0.72', 'groupId': 'OG003', 'lowerLimit': '-1.45', 'upperLimit': '0.01'}]}]}, {'title': 'Phase B, Month 11', 'categories': [{'measurements': [{'value': '-0.80', 'groupId': 'OG000', 'lowerLimit': '-1.62', 'upperLimit': '0.01'}, {'value': '-0.56', 'groupId': 'OG001', 'lowerLimit': '-2.05', 'upperLimit': '0.92'}, {'value': '-0.58', 'groupId': 'OG002', 'lowerLimit': '-1.35', 'upperLimit': '0.20'}, {'value': '-0.57', 'groupId': 'OG003', 'lowerLimit': '-1.26', 'upperLimit': '0.11'}]}]}, {'title': 'Phase B, Month 12', 'categories': [{'measurements': [{'value': '-0.75', 'groupId': 'OG000', 'lowerLimit': '-1.60', 'upperLimit': '0.10'}, {'value': '-1.20', 'groupId': 'OG001', 'lowerLimit': '-2.75', 'upperLimit': '0.35'}, {'value': '-0.75', 'groupId': 'OG002', 'lowerLimit': '-1.56', 'upperLimit': '0.06'}, {'value': '-0.84', 'groupId': 'OG003', 'lowerLimit': '-1.56', 'upperLimit': '-0.13'}]}]}, {'title': 'Phase B, Month 13', 'categories': [{'measurements': [{'value': '-0.91', 'groupId': 'OG000', 'lowerLimit': '-1.75', 'upperLimit': '-0.08'}, {'value': '-0.96', 'groupId': 'OG001', 'lowerLimit': '-2.47', 'upperLimit': '0.56'}, {'value': '-0.86', 'groupId': 'OG002', 'lowerLimit': '-1.65', 'upperLimit': '-0.06'}, {'value': '-0.88', 'groupId': 'OG003', 'lowerLimit': '-1.58', 'upperLimit': '-0.18'}]}]}, {'title': 'Phase B, Month 14', 'categories': [{'measurements': [{'value': '-0.81', 'groupId': 'OG000', 'lowerLimit': '-1.69', 'upperLimit': '0.06'}, {'value': '-0.67', 'groupId': 'OG001', 'lowerLimit': '-2.26', 'upperLimit': '0.92'}, {'value': '-0.27', 'groupId': 'OG002', 'lowerLimit': '-1.10', 'upperLimit': '0.57'}, {'value': '-0.35', 'groupId': 'OG003', 'lowerLimit': '-1.09', 'upperLimit': '0.38'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During 14 months', 'description': 'The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.\n\nAdditional concerns consist of 12 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the additional concerns ranges from 0 to 48. Higher scores represent better QoL.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'OG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."}, {'id': 'OG003', 'title': 'Total Continuous', 'description': 'This is the combination of degarelix continuous and leuprolide continuous treatment arms.'}], 'classes': [{'title': 'Phase A, Month 3', 'categories': [{'measurements': [{'value': '-1.86', 'groupId': 'OG000', 'lowerLimit': '-3.62', 'upperLimit': '-0.10'}, {'value': '-1.89', 'groupId': 'OG001', 'lowerLimit': '-5.13', 'upperLimit': '1.34'}, {'value': '-1.23', 'groupId': 'OG002', 'lowerLimit': '-2.92', 'upperLimit': '0.45'}, {'value': '-1.37', 'groupId': 'OG003', 'lowerLimit': '-2.87', 'upperLimit': '0.12'}]}]}, {'title': 'Phase A, Month 7', 'categories': [{'measurements': [{'value': '-2.03', 'groupId': 'OG000', 'lowerLimit': '-3.87', 'upperLimit': '-0.19'}, {'value': '-2.64', 'groupId': 'OG001', 'lowerLimit': '-6.03', 'upperLimit': '0.76'}, {'value': '-2.38', 'groupId': 'OG002', 'lowerLimit': '-4.12', 'upperLimit': '-0.63'}, {'value': '-2.43', 'groupId': 'OG003', 'lowerLimit': '-3.98', 'upperLimit': '-0.88'}]}]}, {'title': 'Phase B, Month 8', 'categories': [{'measurements': [{'value': '-1.75', 'groupId': 'OG000', 'lowerLimit': '-3.45', 'upperLimit': '-0.04'}, {'value': '-3.12', 'groupId': 'OG001', 'lowerLimit': '-6.26', 'upperLimit': '0.03'}, {'value': '-1.69', 'groupId': 'OG002', 'lowerLimit': '-3.31', 'upperLimit': '-0.07'}, {'value': '-1.99', 'groupId': 'OG003', 'lowerLimit': '-3.42', 'upperLimit': '-0.55'}]}]}, {'title': 'Phase B, Month 9', 'categories': [{'measurements': [{'value': '-1.61', 'groupId': 'OG000', 'lowerLimit': '-3.46', 'upperLimit': '0.23'}, {'value': '-3.49', 'groupId': 'OG001', 'lowerLimit': '-6.89', 'upperLimit': '-0.10'}, {'value': '-2.84', 'groupId': 'OG002', 'lowerLimit': '-4.59', 'upperLimit': '-1.09'}, {'value': '-2.98', 'groupId': 'OG003', 'lowerLimit': '-4.53', 'upperLimit': '-1.42'}]}]}, {'title': 'Phase B, Month 10', 'categories': [{'measurements': [{'value': '-0.89', 'groupId': 'OG000', 'lowerLimit': '-2.84', 'upperLimit': '1.05'}, {'value': '-4.56', 'groupId': 'OG001', 'lowerLimit': '-8.15', 'upperLimit': '-0.98'}, {'value': '-3.16', 'groupId': 'OG002', 'lowerLimit': '-5.01', 'upperLimit': '-1.31'}, {'value': '-3.45', 'groupId': 'OG003', 'lowerLimit': '-5.09', 'upperLimit': '-1.81'}]}]}, {'title': 'Phase B, Month 11', 'categories': [{'measurements': [{'value': '-1.18', 'groupId': 'OG000', 'lowerLimit': '-3.10', 'upperLimit': '0.73'}, {'value': '-3.27', 'groupId': 'OG001', 'lowerLimit': '-6.79', 'upperLimit': '0.26'}, {'value': '-2.48', 'groupId': 'OG002', 'lowerLimit': '-4.30', 'upperLimit': '-0.67'}, {'value': '-2.65', 'groupId': 'OG003', 'lowerLimit': '-4.26', 'upperLimit': '-1.04'}]}]}, {'title': 'Phase B, Month 12', 'categories': [{'measurements': [{'value': '-0.95', 'groupId': 'OG000', 'lowerLimit': '-2.88', 'upperLimit': '0.98'}, {'value': '-3.97', 'groupId': 'OG001', 'lowerLimit': '-7.52', 'upperLimit': '-0.42'}, {'value': '-1.60', 'groupId': 'OG002', 'lowerLimit': '-3.43', 'upperLimit': '0.23'}, {'value': '-2.09', 'groupId': 'OG003', 'lowerLimit': '-3.72', 'upperLimit': '-0.47'}]}]}, {'title': 'Phase B, Month 13', 'categories': [{'measurements': [{'value': '-1.74', 'groupId': 'OG000', 'lowerLimit': '-3.72', 'upperLimit': '0.24'}, {'value': '-5.62', 'groupId': 'OG001', 'lowerLimit': '-9.26', 'upperLimit': '-1.97'}, {'value': '-1.85', 'groupId': 'OG002', 'lowerLimit': '-3.73', 'upperLimit': '0.02'}, {'value': '-2.64', 'groupId': 'OG003', 'lowerLimit': '-4.32', 'upperLimit': '-0.97'}]}]}, {'title': 'Phase B, Month 14', 'categories': [{'measurements': [{'value': '-1.36', 'groupId': 'OG000', 'lowerLimit': '-3.24', 'upperLimit': '0.52'}, {'value': '-4.28', 'groupId': 'OG001', 'lowerLimit': '-7.75', 'upperLimit': '-0.81'}, {'value': '-1.65', 'groupId': 'OG002', 'lowerLimit': '-3.44', 'upperLimit': '0.13'}, {'value': '-2.20', 'groupId': 'OG003', 'lowerLimit': '-3.79', 'upperLimit': '-0.61'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During 14 months', 'description': 'The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Total FACT-P scores ranges from 0 to 156. Higher scores represent better QoL.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'OG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."}, {'id': 'OG003', 'title': 'Total Continuous', 'description': 'This is the combination of degarelix continuous and leuprolide continuous treatment arms.'}], 'classes': [{'title': 'Phase A, Month 3', 'categories': [{'measurements': [{'value': '-1.57', 'groupId': 'OG000', 'lowerLimit': '-1.83', 'upperLimit': '-1.32'}, {'value': '-1.57', 'groupId': 'OG001', 'lowerLimit': '-2.04', 'upperLimit': '-1.10'}, {'value': '-1.27', 'groupId': 'OG002', 'lowerLimit': '-1.51', 'upperLimit': '-1.03'}, {'value': '-1.33', 'groupId': 'OG003', 'lowerLimit': '-1.55', 'upperLimit': '-1.12'}]}]}, {'title': 'Phase A, Month 7', 'categories': [{'measurements': [{'value': '-1.71', 'groupId': 'OG000', 'lowerLimit': '-1.96', 'upperLimit': '-1.47'}, {'value': '-1.39', 'groupId': 'OG001', 'lowerLimit': '-1.84', 'upperLimit': '-0.94'}, {'value': '-1.67', 'groupId': 'OG002', 'lowerLimit': '-1.90', 'upperLimit': '-1.44'}, {'value': '-1.61', 'groupId': 'OG003', 'lowerLimit': '-1.82', 'upperLimit': '-1.41'}]}]}, {'title': 'Phase B, Month 9', 'categories': [{'measurements': [{'value': '-1.72', 'groupId': 'OG000', 'lowerLimit': '-1.98', 'upperLimit': '-1.46'}, {'value': '-1.51', 'groupId': 'OG001', 'lowerLimit': '-1.99', 'upperLimit': '-1.02'}, {'value': '-1.62', 'groupId': 'OG002', 'lowerLimit': '-1.87', 'upperLimit': '-1.37'}, {'value': '-1.60', 'groupId': 'OG003', 'lowerLimit': '-1.82', 'upperLimit': '-1.38'}]}]}, {'title': 'Phase B, Month 11', 'categories': [{'measurements': [{'value': '-1.59', 'groupId': 'OG000', 'lowerLimit': '-1.85', 'upperLimit': '-1.34'}, {'value': '-1.52', 'groupId': 'OG001', 'lowerLimit': '-1.99', 'upperLimit': '-1.05'}, {'value': '-1.65', 'groupId': 'OG002', 'lowerLimit': '-1.89', 'upperLimit': '-1.42'}, {'value': '-1.63', 'groupId': 'OG003', 'lowerLimit': '-1.84', 'upperLimit': '-1.41'}]}]}, {'title': 'Phase B, Month 13', 'categories': [{'measurements': [{'value': '-1.44', 'groupId': 'OG000', 'lowerLimit': '-1.69', 'upperLimit': '-1.19'}, {'value': '-1.55', 'groupId': 'OG001', 'lowerLimit': '-2.02', 'upperLimit': '-1.08'}, {'value': '-1.72', 'groupId': 'OG002', 'lowerLimit': '-1.96', 'upperLimit': '-1.48'}, {'value': '-1.69', 'groupId': 'OG003', 'lowerLimit': '-1.90', 'upperLimit': '-1.47'}]}]}, {'title': 'Phase B, Month 14', 'categories': [{'measurements': [{'value': '-1.30', 'groupId': 'OG000', 'lowerLimit': '-1.55', 'upperLimit': '-1.04'}, {'value': '-1.65', 'groupId': 'OG001', 'lowerLimit': '-2.12', 'upperLimit': '-1.17'}, {'value': '-1.72', 'groupId': 'OG002', 'lowerLimit': '-1.96', 'upperLimit': '-1.48'}, {'value': '-1.71', 'groupId': 'OG003', 'lowerLimit': '-1.92', 'upperLimit': '-1.49'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During 14 months', 'description': 'The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.\n\nSexual drive domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the sexual drive domain ranges from 0 to 8. A higher scores represent better sexual function.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sexual Function as Assessed by the SFI: Erection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'OG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."}, {'id': 'OG003', 'title': 'Total Continuous', 'description': 'This is the combination of degarelix continuous and leuprolide continuous treatment arms.'}], 'classes': [{'title': 'Phase A, Month 3', 'categories': [{'measurements': [{'value': '-1.32', 'groupId': 'OG000', 'lowerLimit': '-1.62', 'upperLimit': '-1.01'}, {'value': '-0.91', 'groupId': 'OG001', 'lowerLimit': '-1.48', 'upperLimit': '-0.35'}, {'value': '-1.21', 'groupId': 'OG002', 'lowerLimit': '-1.50', 'upperLimit': '-0.91'}, {'value': '-1.14', 'groupId': 'OG003', 'lowerLimit': '-1.40', 'upperLimit': '-0.89'}]}]}, {'title': 'Phase A, Month 7', 'categories': [{'measurements': [{'value': '-1.43', 'groupId': 'OG000', 'lowerLimit': '-1.75', 'upperLimit': '-1.11'}, {'value': '-1.06', 'groupId': 'OG001', 'lowerLimit': '-1.65', 'upperLimit': '-0.47'}, {'value': '-1.34', 'groupId': 'OG002', 'lowerLimit': '-1.65', 'upperLimit': '-1.03'}, {'value': '-1.28', 'groupId': 'OG003', 'lowerLimit': '-1.55', 'upperLimit': '-1.01'}]}]}, {'title': 'Phase B, Month 9', 'categories': [{'measurements': [{'value': '-1.52', 'groupId': 'OG000', 'lowerLimit': '-1.80', 'upperLimit': '-1.23'}, {'value': '-1.07', 'groupId': 'OG001', 'lowerLimit': '-1.60', 'upperLimit': '-0.54'}, {'value': '-1.46', 'groupId': 'OG002', 'lowerLimit': '-1.74', 'upperLimit': '-1.19'}, {'value': '-1.38', 'groupId': 'OG003', 'lowerLimit': '-1.62', 'upperLimit': '-1.14'}]}]}, {'title': 'Phase B, Month 11', 'categories': [{'measurements': [{'value': '-1.15', 'groupId': 'OG000', 'lowerLimit': '-1.44', 'upperLimit': '-0.86'}, {'value': '-1.34', 'groupId': 'OG001', 'lowerLimit': '-1.88', 'upperLimit': '-0.80'}, {'value': '-1.28', 'groupId': 'OG002', 'lowerLimit': '-1.56', 'upperLimit': '-1.01'}, {'value': '-1.30', 'groupId': 'OG003', 'lowerLimit': '-1.54', 'upperLimit': '-1.05'}]}]}, {'title': 'Phase B, Month 13', 'categories': [{'measurements': [{'value': '-0.97', 'groupId': 'OG000', 'lowerLimit': '-1.30', 'upperLimit': '-0.64'}, {'value': '-1.36', 'groupId': 'OG001', 'lowerLimit': '-1.97', 'upperLimit': '-0.74'}, {'value': '-1.33', 'groupId': 'OG002', 'lowerLimit': '-1.65', 'upperLimit': '-1.02'}, {'value': '-1.34', 'groupId': 'OG003', 'lowerLimit': '-1.62', 'upperLimit': '-1.06'}]}]}, {'title': 'Phase B, Month 14', 'categories': [{'measurements': [{'value': '-0.90', 'groupId': 'OG000', 'lowerLimit': '-1.25', 'upperLimit': '-0.56'}, {'value': '-1.43', 'groupId': 'OG001', 'lowerLimit': '-2.08', 'upperLimit': '-0.79'}, {'value': '-1.26', 'groupId': 'OG002', 'lowerLimit': '-1.59', 'upperLimit': '-0.93'}, {'value': '-1.29', 'groupId': 'OG003', 'lowerLimit': '-1.59', 'upperLimit': '-1.00'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During 14 months', 'description': 'The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.\n\nErection domain consist of 3 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the erection domain ranges from 0 to 12. A higher scores represent better sexual function.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'OG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."}, {'id': 'OG003', 'title': 'Total Continuous', 'description': 'This is the combination of degarelix continuous and leuprolide continuous treatment arms.'}], 'classes': [{'title': 'Phase A, Month 3', 'categories': [{'measurements': [{'value': '-1.04', 'groupId': 'OG000', 'lowerLimit': '-1.33', 'upperLimit': '-0.75'}, {'value': '-0.90', 'groupId': 'OG001', 'lowerLimit': '-1.43', 'upperLimit': '-0.37'}, {'value': '-0.87', 'groupId': 'OG002', 'lowerLimit': '-1.15', 'upperLimit': '-0.59'}, {'value': '-0.88', 'groupId': 'OG003', 'lowerLimit': '-1.13', 'upperLimit': '-0.63'}]}]}, {'title': 'Phase A, Month 7', 'categories': [{'measurements': [{'value': '-1.23', 'groupId': 'OG000', 'lowerLimit': '-1.48', 'upperLimit': '-0.97'}, {'value': '-0.80', 'groupId': 'OG001', 'lowerLimit': '-1.27', 'upperLimit': '-0.34'}, {'value': '-1.08', 'groupId': 'OG002', 'lowerLimit': '-1.32', 'upperLimit': '-0.84'}, {'value': '-1.02', 'groupId': 'OG003', 'lowerLimit': '-1.23', 'upperLimit': '-0.80'}]}]}, {'title': 'Phase B, Month 9', 'categories': [{'measurements': [{'value': '-1.24', 'groupId': 'OG000', 'lowerLimit': '-1.51', 'upperLimit': '-0.98'}, {'value': '-1.06', 'groupId': 'OG001', 'lowerLimit': '-1.55', 'upperLimit': '-0.57'}, {'value': '-0.94', 'groupId': 'OG002', 'lowerLimit': '-1.20', 'upperLimit': '-0.69'}, {'value': '-0.97', 'groupId': 'OG003', 'lowerLimit': '-1.20', 'upperLimit': '-0.74'}]}]}, {'title': 'Phase B, Month 11', 'categories': [{'measurements': [{'value': '-0.94', 'groupId': 'OG000', 'lowerLimit': '-1.22', 'upperLimit': '-0.67'}, {'value': '-1.24', 'groupId': 'OG001', 'lowerLimit': '-1.74', 'upperLimit': '-0.74'}, {'value': '-0.93', 'groupId': 'OG002', 'lowerLimit': '-1.19', 'upperLimit': '-0.67'}, {'value': '-1.00', 'groupId': 'OG003', 'lowerLimit': '-1.23', 'upperLimit': '-0.76'}]}]}, {'title': 'Phase B, Month 13', 'categories': [{'measurements': [{'value': '-0.89', 'groupId': 'OG000', 'lowerLimit': '-1.15', 'upperLimit': '-0.62'}, {'value': '-1.07', 'groupId': 'OG001', 'lowerLimit': '-1.56', 'upperLimit': '-0.58'}, {'value': '-1.12', 'groupId': 'OG002', 'lowerLimit': '-1.38', 'upperLimit': '-0.87'}, {'value': '-1.11', 'groupId': 'OG003', 'lowerLimit': '-1.34', 'upperLimit': '-0.89'}]}]}, {'title': 'Phase B, Month 14', 'categories': [{'measurements': [{'value': '-0.79', 'groupId': 'OG000', 'lowerLimit': '-1.10', 'upperLimit': '-0.48'}, {'value': '-1.17', 'groupId': 'OG001', 'lowerLimit': '-1.73', 'upperLimit': '-0.61'}, {'value': '-0.97', 'groupId': 'OG002', 'lowerLimit': '-1.27', 'upperLimit': '-0.68'}, {'value': '-1.01', 'groupId': 'OG003', 'lowerLimit': '-1.27', 'upperLimit': '-0.75'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During 14 months', 'description': 'The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.\n\nEjaculation domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the ejaculation domain ranges from 0 to 8. A higher scores represent better sexual function.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'OG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."}, {'id': 'OG003', 'title': 'Total Continuous', 'description': 'This is the combination of degarelix continuous and leuprolide continuous treatment arms.'}], 'classes': [{'title': 'Phase A, Month 3', 'categories': [{'measurements': [{'value': '-0.26', 'groupId': 'OG000', 'lowerLimit': '-0.93', 'upperLimit': '0.41'}, {'value': '-0.58', 'groupId': 'OG001', 'lowerLimit': '-1.82', 'upperLimit': '0.66'}, {'value': '-0.36', 'groupId': 'OG002', 'lowerLimit': '-1.00', 'upperLimit': '0.28'}, {'value': '-0.40', 'groupId': 'OG003', 'lowerLimit': '-0.97', 'upperLimit': '0.16'}]}]}, {'title': 'Phase A, Month 7', 'categories': [{'measurements': [{'value': '-0.90', 'groupId': 'OG000', 'lowerLimit': '-1.60', 'upperLimit': '-0.19'}, {'value': '-0.88', 'groupId': 'OG001', 'lowerLimit': '-2.19', 'upperLimit': '0.44'}, {'value': '-0.57', 'groupId': 'OG002', 'lowerLimit': '-1.25', 'upperLimit': '0.11'}, {'value': '-0.63', 'groupId': 'OG003', 'lowerLimit': '-1.23', 'upperLimit': '-0.03'}]}]}, {'title': 'Phase B, Month 9', 'categories': [{'measurements': [{'value': '-0.56', 'groupId': 'OG000', 'lowerLimit': '-1.30', 'upperLimit': '0.17'}, {'value': '-0.71', 'groupId': 'OG001', 'lowerLimit': '-2.07', 'upperLimit': '0.65'}, {'value': '-0.64', 'groupId': 'OG002', 'lowerLimit': '-1.34', 'upperLimit': '0.06'}, {'value': '-0.66', 'groupId': 'OG003', 'lowerLimit': '-1.28', 'upperLimit': '-0.03'}]}]}, {'title': 'Phase B, Month 11', 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '-0.65', 'upperLimit': '0.83'}, {'value': '-0.53', 'groupId': 'OG001', 'lowerLimit': '-1.90', 'upperLimit': '0.84'}, {'value': '-0.98', 'groupId': 'OG002', 'lowerLimit': '-1.68', 'upperLimit': '-0.27'}, {'value': '-0.89', 'groupId': 'OG003', 'lowerLimit': '-1.51', 'upperLimit': '-0.26'}]}]}, {'title': 'Phase B, Month 13', 'categories': [{'measurements': [{'value': '-0.15', 'groupId': 'OG000', 'lowerLimit': '-0.88', 'upperLimit': '0.58'}, {'value': '-1.63', 'groupId': 'OG001', 'lowerLimit': '-2.99', 'upperLimit': '-0.27'}, {'value': '-1.07', 'groupId': 'OG002', 'lowerLimit': '-1.77', 'upperLimit': '-0.38'}, {'value': '-1.19', 'groupId': 'OG003', 'lowerLimit': '-1.81', 'upperLimit': '-0.57'}]}]}, {'title': 'Phase B, Month 14', 'categories': [{'measurements': [{'value': '-0.31', 'groupId': 'OG000', 'lowerLimit': '-1.04', 'upperLimit': '0.41'}, {'value': '-1.68', 'groupId': 'OG001', 'lowerLimit': '-3.03', 'upperLimit': '-0.33'}, {'value': '-0.89', 'groupId': 'OG002', 'lowerLimit': '-1.58', 'upperLimit': '-0.19'}, {'value': '-1.05', 'groupId': 'OG003', 'lowerLimit': '-1.67', 'upperLimit': '-0.44'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During 14 months', 'description': 'The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.\n\nProblem assessment domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the problem assessment domain ranges from 0 to 8. A higher scores represent better sexual function.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'OG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."}, {'id': 'OG003', 'title': 'Total Continuous', 'description': 'This is the combination of degarelix continuous and leuprolide continuous treatment arms.'}], 'classes': [{'title': 'Phase A, Month 3', 'categories': [{'measurements': [{'value': '-0.32', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '-0.13'}, {'value': '-0.18', 'groupId': 'OG001', 'lowerLimit': '-0.53', 'upperLimit': '0.16'}, {'value': '-0.27', 'groupId': 'OG002', 'lowerLimit': '-0.45', 'upperLimit': '-0.09'}, {'value': '-0.25', 'groupId': 'OG003', 'lowerLimit': '-0.41', 'upperLimit': '-0.10'}]}]}, {'title': 'Phase A, Month 7', 'categories': [{'measurements': [{'value': '-0.28', 'groupId': 'OG000', 'lowerLimit': '-0.48', 'upperLimit': '-0.07'}, {'value': '-0.37', 'groupId': 'OG001', 'lowerLimit': '-0.74', 'upperLimit': '0.01'}, {'value': '-0.40', 'groupId': 'OG002', 'lowerLimit': '-0.59', 'upperLimit': '-0.21'}, {'value': '-0.39', 'groupId': 'OG003', 'lowerLimit': '-0.56', 'upperLimit': '-0.22'}]}]}, {'title': 'Phase B, Month 9', 'categories': [{'measurements': [{'value': '-0.33', 'groupId': 'OG000', 'lowerLimit': '-0.53', 'upperLimit': '-0.13'}, {'value': '-0.34', 'groupId': 'OG001', 'lowerLimit': '-0.71', 'upperLimit': '0.03'}, {'value': '-0.41', 'groupId': 'OG002', 'lowerLimit': '-0.60', 'upperLimit': '-0.22'}, {'value': '-0.39', 'groupId': 'OG003', 'lowerLimit': '-0.56', 'upperLimit': '-0.23'}]}]}, {'title': 'Phase B, Month 11', 'categories': [{'measurements': [{'value': '-0.15', 'groupId': 'OG000', 'lowerLimit': '-0.35', 'upperLimit': '0.05'}, {'value': '-0.47', 'groupId': 'OG001', 'lowerLimit': '-0.85', 'upperLimit': '-0.09'}, {'value': '-0.41', 'groupId': 'OG002', 'lowerLimit': '-0.60', 'upperLimit': '-0.21'}, {'value': '-0.42', 'groupId': 'OG003', 'lowerLimit': '-0.59', 'upperLimit': '-0.25'}]}]}, {'title': 'Phase B, Month 13', 'categories': [{'measurements': [{'value': '-0.11', 'groupId': 'OG000', 'lowerLimit': '-0.32', 'upperLimit': '0.09'}, {'value': '-0.57', 'groupId': 'OG001', 'lowerLimit': '-0.95', 'upperLimit': '-0.20'}, {'value': '-0.42', 'groupId': 'OG002', 'lowerLimit': '-0.61', 'upperLimit': '-0.23'}, {'value': '-0.45', 'groupId': 'OG003', 'lowerLimit': '-0.62', 'upperLimit': '-0.28'}]}]}, {'title': 'Phase B, Month 14', 'categories': [{'measurements': [{'value': '-0.12', 'groupId': 'OG000', 'lowerLimit': '-0.32', 'upperLimit': '0.08'}, {'value': '-0.70', 'groupId': 'OG001', 'lowerLimit': '-1.08', 'upperLimit': '-0.33'}, {'value': '-0.37', 'groupId': 'OG002', 'lowerLimit': '-0.57', 'upperLimit': '-0.18'}, {'value': '-0.44', 'groupId': 'OG003', 'lowerLimit': '-0.61', 'upperLimit': '-0.27'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During 14 months', 'description': 'The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.\n\nOverall satisfaction domain consist of single question and is scored on a scale of 0-4 (0=minimum, 4=maximum). A higher score represent better sexual function.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'OG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."}, {'id': 'OG003', 'title': 'Total Continuous', 'description': 'This is the combination of degarelix continuous and leuprolide continuous treatment arms.'}], 'classes': [{'title': 'Phase A, Month 3', 'categories': [{'measurements': [{'value': '-4.07', 'groupId': 'OG000', 'lowerLimit': '-5.10', 'upperLimit': '-3.05'}, {'value': '-3.93', 'groupId': 'OG001', 'lowerLimit': '-5.84', 'upperLimit': '-2.02'}, {'value': '-3.69', 'groupId': 'OG002', 'lowerLimit': '-4.67', 'upperLimit': '-2.71'}, {'value': '-3.74', 'groupId': 'OG003', 'lowerLimit': '-4.61', 'upperLimit': '-2.87'}]}]}, {'title': 'Phase A, Month 7', 'categories': [{'measurements': [{'value': '-5.20', 'groupId': 'OG000', 'lowerLimit': '-6.23', 'upperLimit': '-4.16'}, {'value': '-4.28', 'groupId': 'OG001', 'lowerLimit': '-6.21', 'upperLimit': '-2.35'}, {'value': '-4.57', 'groupId': 'OG002', 'lowerLimit': '-5.56', 'upperLimit': '-3.58'}, {'value': '-4.51', 'groupId': 'OG003', 'lowerLimit': '-5.38', 'upperLimit': '-3.63'}]}]}, {'title': 'Phase B, Month 9', 'categories': [{'measurements': [{'value': '-4.97', 'groupId': 'OG000', 'lowerLimit': '-6.04', 'upperLimit': '-3.91'}, {'value': '-4.35', 'groupId': 'OG001', 'lowerLimit': '-6.33', 'upperLimit': '-2.37'}, {'value': '-4.62', 'groupId': 'OG002', 'lowerLimit': '-5.63', 'upperLimit': '-3.61'}, {'value': '-4.56', 'groupId': 'OG003', 'lowerLimit': '-5.46', 'upperLimit': '-3.66'}]}]}, {'title': 'Phase B, Month 11', 'categories': [{'measurements': [{'value': '-3.56', 'groupId': 'OG000', 'lowerLimit': '-4.63', 'upperLimit': '-2.49'}, {'value': '-4.62', 'groupId': 'OG001', 'lowerLimit': '-6.62', 'upperLimit': '-2.63'}, {'value': '-4.74', 'groupId': 'OG002', 'lowerLimit': '-5.76', 'upperLimit': '-3.72'}, {'value': '-4.71', 'groupId': 'OG003', 'lowerLimit': '-5.62', 'upperLimit': '-3.81'}]}]}, {'title': 'Phase B, Month 13', 'categories': [{'measurements': [{'value': '-3.37', 'groupId': 'OG000', 'lowerLimit': '-4.48', 'upperLimit': '-2.26'}, {'value': '-5.59', 'groupId': 'OG001', 'lowerLimit': '-7.66', 'upperLimit': '-3.52'}, {'value': '-5.15', 'groupId': 'OG002', 'lowerLimit': '-6.21', 'upperLimit': '-4.09'}, {'value': '-5.24', 'groupId': 'OG003', 'lowerLimit': '-6.18', 'upperLimit': '-4.30'}]}]}, {'title': 'Phase B, Month 14', 'categories': [{'measurements': [{'value': '-3.27', 'groupId': 'OG000', 'lowerLimit': '-4.41', 'upperLimit': '-2.12'}, {'value': '-5.93', 'groupId': 'OG001', 'lowerLimit': '-8.06', 'upperLimit': '-3.80'}, {'value': '-4.68', 'groupId': 'OG002', 'lowerLimit': '-5.77', 'upperLimit': '-3.59'}, {'value': '-4.94', 'groupId': 'OG003', 'lowerLimit': '-5.91', 'upperLimit': '-3.97'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During 14 months', 'description': 'The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Total SFI score ranges from 0 to 44. A higher scores represent better sexual function.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'OG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.3', 'upperLimit': '100'}, {'value': '97.6', 'groupId': 'OG001', 'lowerLimit': '87.1', 'upperLimit': '99.9'}, {'value': '98.7', 'groupId': 'OG002', 'lowerLimit': '95.3', 'upperLimit': '99.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 14 months', 'description': 'Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL was measured during the study period.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Time to Return to Testosterone >0.5 ng/mL Level in the DI Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}], 'classes': [{'categories': [{'measurements': [{'value': '112.0', 'groupId': 'OG000', 'lowerLimit': '112.0', 'upperLimit': '140.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During Phase B', 'description': 'The time to testosterone \\>0.5 ng/mL level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix)', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Time to Return to Normal Range (≥1.5 ng/mL) or Baseline Testosterone Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}], 'classes': [{'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000', 'lowerLimit': '140.0', 'upperLimit': '168.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During Phase B', 'description': 'The time to return to normal range (≥1.5 ng/mL) or Baseline testosterone level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix).', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Serum Testosterone Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'OG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."}], 'classes': [{'title': 'Phase A, Visit 1 (Day 0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.', 'groupId': 'OG000'}, {'value': '-2.97', 'spread': 'NA', 'comment': 'One patient erroneously received medication prior to this visit. Thus, the value obtained on this visit was considered as first post-baseline value for this patient and is reported. There was no SD.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 2 (Month 1)', 'categories': [{'measurements': [{'value': '-3.64', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-3.77', 'spread': '1.43', 'groupId': 'OG001'}, {'value': '-3.7', 'spread': '1.56', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 3 (Month 2)', 'categories': [{'measurements': [{'value': '-3.67', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-3.77', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '-3.77', 'spread': '1.56', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 4 (Month 3)', 'categories': [{'measurements': [{'value': '-3.68', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-3.78', 'spread': '1.43', 'groupId': 'OG001'}, {'value': '-3.77', 'spread': '1.55', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 5 (Month 4)', 'categories': [{'measurements': [{'value': '-3.67', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '-3.78', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '-3.74', 'spread': '1.61', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 6 (Month 5)', 'categories': [{'measurements': [{'value': '-3.67', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '-3.78', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '-3.78', 'spread': '1.55', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 7 (Month 6)', 'categories': [{'measurements': [{'value': '-3.66', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '-3.77', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '-3.77', 'spread': '1.56', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 8 (Month 7)', 'categories': [{'measurements': [{'value': '-3.66', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '-3.78', 'spread': '1.43', 'groupId': 'OG001'}, {'value': '-3.78', 'spread': '1.55', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 9 (Month 8)', 'categories': [{'measurements': [{'value': '-3.63', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '-3.76', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '-3.78', 'spread': '1.56', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 10 (Month 9)', 'categories': [{'measurements': [{'value': '-3.41', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-3.76', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '-3.78', 'spread': '1.56', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 11 (Month 10)', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '-3.75', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '-3.77', 'spread': '1.57', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 12 (Month 11)', 'categories': [{'measurements': [{'value': '-2.57', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '-3.74', 'spread': '1.43', 'groupId': 'OG001'}, {'value': '-3.78', 'spread': '1.55', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 13 (Month 12)', 'categories': [{'measurements': [{'value': '-2.18', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '-3.72', 'spread': '1.43', 'groupId': 'OG001'}, {'value': '-3.78', 'spread': '1.56', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 14 (Month 13)', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '-3.73', 'spread': '1.42', 'groupId': 'OG001'}, {'value': '-3.77', 'spread': '1.57', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 15 (Month 14)', 'categories': [{'measurements': [{'value': '-1.77', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '-3.71', 'spread': '1.42', 'groupId': 'OG001'}, {'value': '-3.78', 'spread': '1.56', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Phase A Visit 1-8 and Phase B Visit 9-15.', 'description': 'Absolute Change From Baseline in Serum Testosterone Levels was measured.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Serum Testosterone Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'OG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'OG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."}], 'classes': [{'title': 'Phase A, Visit 1 (Day 0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.', 'groupId': 'OG000'}, {'value': '-95.8', 'spread': 'NA', 'comment': 'One patient erroneously received medication prior to this visit. Thus, the value obtained on this visit was considered as first post-baseline value for this patient and is reported. There was no SD.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 2 (Month 1)', 'categories': [{'measurements': [{'value': '-96.4', 'spread': '5.26', 'groupId': 'OG000'}, {'value': '-97.4', 'spread': '2.31', 'groupId': 'OG001'}, {'value': '-95.5', 'spread': '4.22', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 3 (Month 2)', 'categories': [{'measurements': [{'value': '-97.3', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '-97.5', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '-97.7', 'spread': '1.44', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 4 (Month 3)', 'categories': [{'measurements': [{'value': '-97.5', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '-97.8', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '-97.5', 'spread': '1.76', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 5 (Month 4)', 'categories': [{'measurements': [{'value': '-97.2', 'spread': '4.26', 'groupId': 'OG000'}, {'value': '-97.7', 'spread': '1.58', 'groupId': 'OG001'}, {'value': '-96.2', 'spread': '14', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 6 (Month 5)', 'categories': [{'measurements': [{'value': '-97.3', 'spread': '4.42', 'groupId': 'OG000'}, {'value': '-97.6', 'spread': '2.49', 'groupId': 'OG001'}, {'value': '-97.8', 'spread': '1.36', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 7 (Month 6)', 'categories': [{'measurements': [{'value': '-96.8', 'spread': '7.01', 'groupId': 'OG000'}, {'value': '-97.6', 'spread': '2.03', 'groupId': 'OG001'}, {'value': '-97.9', 'spread': '1.46', 'groupId': 'OG002'}]}]}, {'title': 'Phase A, Visit 8 (Month 7)', 'categories': [{'measurements': [{'value': '-96.9', 'spread': '6.34', 'groupId': 'OG000'}, {'value': '-97.5', 'spread': '2.54', 'groupId': 'OG001'}, {'value': '-97.7', 'spread': '1.67', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 9 (Month 8)', 'categories': [{'measurements': [{'value': '-95.6', 'spread': '9.69', 'groupId': 'OG000'}, {'value': '-97.1', 'spread': '3.09', 'groupId': 'OG001'}, {'value': '-97.8', 'spread': '1.43', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 10 (Month 9)', 'categories': [{'measurements': [{'value': '-88.7', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '-97', 'spread': '3.14', 'groupId': 'OG001'}, {'value': '-97.7', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 11 (Month 10)', 'categories': [{'measurements': [{'value': '-77', 'spread': '34.8', 'groupId': 'OG000'}, {'value': '-97', 'spread': '3.74', 'groupId': 'OG001'}, {'value': '-97.5', 'spread': '3.49', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 12 (Month 11)', 'categories': [{'measurements': [{'value': '-65.4', 'spread': '37.7', 'groupId': 'OG000'}, {'value': '-96.7', 'spread': '3.43', 'groupId': 'OG001'}, {'value': '-97.9', 'spread': '1.36', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 13 (Month 12)', 'categories': [{'measurements': [{'value': '-54.7', 'spread': '41.5', 'groupId': 'OG000'}, {'value': '-96', 'spread': '5.56', 'groupId': 'OG001'}, {'value': '-97.8', 'spread': '1.45', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 14 (Month 13)', 'categories': [{'measurements': [{'value': '-51.9', 'spread': '43.1', 'groupId': 'OG000'}, {'value': '-96.5', 'spread': '3.7', 'groupId': 'OG001'}, {'value': '-97.4', 'spread': '4.64', 'groupId': 'OG002'}]}]}, {'title': 'Phase B, Visit 15 (Month 14)', 'categories': [{'measurements': [{'value': '-44', 'spread': '66.1', 'groupId': 'OG000'}, {'value': '-95.8', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '-97.7', 'spread': '1.56', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Phase A Visit 1-8 and Phase B Visit 9-15.', 'description': 'Percent change from Baseline in serum testosterone levels was measured.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consist of Full Phase B analysis set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'FG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'FG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Full Analysis Set Patients', 'groupId': 'FG000', 'numSubjects': '175'}, {'comment': 'Full Analysis Set Patients', 'groupId': 'FG001', 'numSubjects': '50'}, {'comment': 'Full Analysis Set Patients', 'groupId': 'FG002', 'numSubjects': '178'}]}, {'type': 'Full Phase B Analysis Set', 'achievements': [{'comment': 'Patients completing 7 months treatment with PSA\\<2 ng/mL, and having one primary efficacy assessment.', 'groupId': 'FG000', 'numSubjects': '137'}, {'comment': 'Patients completing 7 months treatment with PSA\\<2 ng/mL, and having one primary efficacy assessment.', 'groupId': 'FG001', 'numSubjects': '41'}, {'comment': 'Patients completing 7 months treatment with PSA\\<2 ng/mL, and having one primary efficacy assessment.', 'groupId': 'FG002', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'PSA failure (>2 ng/mL) at Visit 8', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'PSA failure (>2 ng/mL) on other visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other (not meeting above criteria)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Of the total 409 patients enrolled, six patients were not dosed either due to randomisation error, failing eligibility criteria or consent withdrawal after being randomised.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}, {'value': '403', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.\n\nDegarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.'}, {'id': 'BG001', 'title': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall\n\nDegarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).'}, {'id': 'BG002', 'title': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0, administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. as per manufacturer's labeling directions at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.\n\nLeuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)"}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.9', 'spread': '8.89', 'groupId': 'BG000'}, {'value': '71.7', 'spread': '8.14', 'groupId': 'BG001'}, {'value': '71.0', 'spread': '8.44', 'groupId': 'BG002'}, {'value': '71.5', 'spread': '8.59', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', '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'}]}, {'title': 'Male', 'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}, {'value': '403', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}, {'value': '368', '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', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': '32', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '316', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.77', 'spread': '0.089', 'groupId': 'BG000'}, {'value': '1.74', 'spread': '0.089', 'groupId': 'BG001'}, {'value': '1.76', 'spread': '0.080', 'groupId': 'BG002'}, {'value': '1.76', 'spread': '0.085', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '90.3', 'spread': '19.4', 'groupId': 'BG000'}, {'value': '88.4', 'spread': '15.8', 'groupId': 'BG001'}, {'value': '91.9', 'spread': '16.9', 'groupId': 'BG002'}, {'value': '90.8', 'spread': '17.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '5.45', 'groupId': 'BG000'}, {'value': '29.2', 'spread': '4.89', 'groupId': 'BG001'}, {'value': '29.6', 'spread': '4.94', 'groupId': 'BG002'}, {'value': '29.2', 'spread': '5.16', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Prostate Specific Antigen (PSA)', 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'spread': '66.3', 'groupId': 'BG000'}, {'value': '15.6', 'spread': '32.2', 'groupId': 'BG001'}, {'value': '10.7', 'spread': '24.4', 'groupId': 'BG002'}, {'value': '13.8', 'spread': '48', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Testosterone', 'classes': [{'categories': [{'measurements': [{'value': '3.65', 'spread': '1.43', 'groupId': 'BG000'}, {'value': '3.90', 'spread': '1.59', 'groupId': 'BG001'}, {'value': '3.76', 'spread': '1.58', 'groupId': 'BG002'}, {'value': '3.73', 'spread': '1.52', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Analysis population consist of Full Analysis Set (FAS), which comprised of subjects who received at least one dose of IMP and had at least one efficacy assessment after dosing.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 409}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'dispFirstSubmitDate': '2013-09-20', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-21', 'studyFirstSubmitDate': '2009-06-25', 'dispFirstSubmitQcDate': '2013-09-20', 'resultsFirstSubmitDate': '2016-05-09', 'studyFirstSubmitQcDate': '2009-06-25', 'dispFirstPostDateStruct': {'date': '2013-09-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-21', 'studyFirstPostDateStruct': {'date': '2009-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL', 'timeFrame': 'At 14 month', 'description': 'Percentage of patients with serum PSA levels ≤4.0 ng/mL at 14 month was presented.'}], 'secondaryOutcomes': [{'measure': 'Absolute Change From Baseline in Serum PSA Levels', 'timeFrame': 'Phase A Visit 1-8 and Phase B Visit 9-15.', 'description': 'Absolute change from Baseline in serum PSA levels during the study period was measured.'}, {'measure': 'Percent Change From Baseline in Serum PSA Levels', 'timeFrame': 'Phase A Visit 1-8 and Phase B Visit 9-15.', 'description': 'Percent change from Baseline in serum PSA levels during the study period was measured.'}, {'measure': 'Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being', 'timeFrame': 'During 14 months', 'description': 'The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.\n\nPhysical well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the physical well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.'}, {'measure': 'Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being', 'timeFrame': 'During 14 months', 'description': 'The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.\n\nEmotional well-being consist of 6 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the emotional well-being sub scale ranges from 0 to 24. Higher scores represent better QoL.Higher scores represent better QoL.'}, {'measure': 'Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being', 'timeFrame': 'During 14 months', 'description': 'The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.\n\nSocial well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the social well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.'}, {'measure': 'Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being', 'timeFrame': 'During 14 months', 'description': 'The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.\n\nFunctional well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the functional well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.'}, {'measure': 'Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns', 'timeFrame': 'During 14 months', 'description': 'The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.\n\nAdditional concerns consist of 12 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the additional concerns ranges from 0 to 48. Higher scores represent better QoL.'}, {'measure': 'Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score', 'timeFrame': 'During 14 months', 'description': 'The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Total FACT-P scores ranges from 0 to 156. Higher scores represent better QoL.'}, {'measure': 'Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive', 'timeFrame': 'During 14 months', 'description': 'The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.\n\nSexual drive domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the sexual drive domain ranges from 0 to 8. A higher scores represent better sexual function.'}, {'measure': 'Change From Baseline in Sexual Function as Assessed by the SFI: Erection', 'timeFrame': 'During 14 months', 'description': 'The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.\n\nErection domain consist of 3 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the erection domain ranges from 0 to 12. A higher scores represent better sexual function.'}, {'measure': 'Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation', 'timeFrame': 'During 14 months', 'description': 'The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.\n\nEjaculation domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the ejaculation domain ranges from 0 to 8. A higher scores represent better sexual function.'}, {'measure': 'Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment', 'timeFrame': 'During 14 months', 'description': 'The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.\n\nProblem assessment domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the problem assessment domain ranges from 0 to 8. A higher scores represent better sexual function.'}, {'measure': 'Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life', 'timeFrame': 'During 14 months', 'description': 'The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.\n\nOverall satisfaction domain consist of single question and is scored on a scale of 0-4 (0=minimum, 4=maximum). A higher score represent better sexual function.'}, {'measure': 'Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score', 'timeFrame': 'During 14 months', 'description': 'The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Total SFI score ranges from 0 to 44. A higher scores represent better sexual function.'}, {'measure': 'Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL', 'timeFrame': 'At 14 months', 'description': 'Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL was measured during the study period.'}, {'measure': 'Time to Return to Testosterone >0.5 ng/mL Level in the DI Treatment Group', 'timeFrame': 'During Phase B', 'description': 'The time to testosterone \\>0.5 ng/mL level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix)'}, {'measure': 'Time to Return to Normal Range (≥1.5 ng/mL) or Baseline Testosterone Level', 'timeFrame': 'During Phase B', 'description': 'The time to return to normal range (≥1.5 ng/mL) or Baseline testosterone level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix).'}, {'measure': 'Absolute Change From Baseline in Serum Testosterone Levels', 'timeFrame': 'Phase A Visit 1-8 and Phase B Visit 9-15.', 'description': 'Absolute Change From Baseline in Serum Testosterone Levels was measured.'}, {'measure': 'Percent Change From Baseline in Serum Testosterone Levels', 'timeFrame': 'Phase A Visit 1-8 and Phase B Visit 9-15.', 'description': 'Percent change from Baseline in serum testosterone levels was measured.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'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': 'The purpose of this study was to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) would show a reduction of negative effects of androgen deprivation therapy by increasing the quality of life while keeping prostate specific antigen (PSA) levels suppressed.', 'detailedDescription': 'This was an open-label, randomized, parallel-arm, multicenter study to determine if degarelix intermittent therapy was non-inferior to continuous androgen deprivation therapy (combination of treatment groups receiving continuous degarelix and leuprolide therapy, respectively) in maintaining PSA levels at ≤ 4.0 ng/mL at 14 months.\n\nThe study consisted of two phases, Phase A and B. During Phase A, patients in the degarelix intermittent and degarelix continuous arms received 7 months of therapy with degarelix one-month depot formulation and patients in the leuprolide continuous arm received leuprolide one-month depot injection (7.5 mg) followed by two 3-month depot (22.5 mg) injections. After 7 months of treatment, patients with a PSA ≤2 ng/mL continued into Phase B.\n\nDuring Phase B, patients in the degarelix intermittent arm had a 7-month off-treatment period. Patients randomized to the degarelix continuous arm and the leuprolide continuous arm continued to receive degarelix or leuprolide depot as in Phase A for the remainder of the 14 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years or older.\n* Raising PSA after prior treatment failure of localized prostate cancer.\n* Has a histological confirmed non-metastatic cancer of the prostate (Gleason graded) based on the most current biopsy.\n* Has a screening testosterone within normal range (≥1.5 ng/mL).\n* Has Eastern Cooperative Oncology Group score of ≤2.\n* Bone scan or CT scan report documenting no evidence of metastasis to the bone or internal organs.\n* Life expectancy of at least 15 months.\n\nExclusion Criteria:\n\n* Taken hormone therapy in the last 6 months prior to entering this study.\n* Being treated with 5-alpha reductase inhibitor at time of enrolment and remained on a stable dose throughout the trial.\n* Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.\n* Has hypersensitivity towards any component of the study drug.\n* Has a previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin within the last five years.\n* Has abnormal laboratory results which in the judgement of the Investigator would affect the patient's health or the outcome of the trial.\n* Has a clinically significant medical condition (other than prostate cancer) including but not limited to; renal, haematological, gastrointestinal, endocrine, cardiac, neurological or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.\n* Has an intellectual incapacity or language barriers precluding adequate understanding or co-operation.\n* Has received an investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of the current trial.\n* Has received ketoconazole or diflucan in the last 28 days preceding the Screening Visit.\n* Has previously participated in any Degarelix trial.\n* Is part of an ongoing trial."}, 'identificationModule': {'nctId': 'NCT00928434', 'briefTitle': 'A Study of Degarelix in Patients With Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Randomized, Controlled, Open-Label Study Investigating the Safety and Efficacy of Degarelix Given Intermittently vs Continuous Androgen Deprivation Therapy With Lupron or Degarelix in Patients With Prostate Cancer With Prior Treatment Failure After Localized Treatment', 'orgStudyIdInfo': {'id': 'FE200486 CS37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DI (Degarelix Intermittent)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nSix maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.\n\nDuring Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.', 'interventionNames': ['Drug: Degarelix']}, {'type': 'EXPERIMENTAL', 'label': 'DC (Degarelix Continuous)', 'description': 'Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.\n\nThirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall', 'interventionNames': ['Drug: Degarelix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LC (Leuprolide Continuous)', 'description': "Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0, administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.\n\nOne injection of 22.5 mg leuprolide 3-month depot was administered i.m. as per manufacturer's labeling directions at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).\n\nOn Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.", 'interventionNames': ['Drug: Leuprolide']}], 'interventions': [{'name': 'Degarelix', 'type': 'DRUG', 'description': 'Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.', 'armGroupLabels': ['DI (Degarelix Intermittent)']}, {'name': 'Degarelix', 'type': 'DRUG', 'description': 'Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).', 'armGroupLabels': ['DC (Degarelix Continuous)']}, {'name': 'Leuprolide', 'type': 'DRUG', 'description': 'Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)', 'armGroupLabels': ['LC (Leuprolide Continuous)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexander City', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Research, Inc', 'geoPoint': {'lat': 32.94401, 'lon': -85.95385}}, {'city': 'Homewood', 'state': 'Alabama', 'country': 'United States', 'facility': 'Urology Center of Alabama, PC', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, 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