Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-30 @ 1:25 PM
Study NCT ID:
NCT00819156
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2009-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose Finding Trial With a New Treatment (Degarelix) for 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'}]}}, '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Degarelix 200/80', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.', 'otherNumAffected': 17, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Degarelix 200/120', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.', 'otherNumAffected': 21, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Degarelix 200/160', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.', 'otherNumAffected': 24, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Degarelix 240/80', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.', 'otherNumAffected': 19, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Degarelix 240/120', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.', 'otherNumAffected': 23, 'seriousNumAffected': 6}, {'id': 'EG005', 'title': 'Degarelix 240/160', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.', 'otherNumAffected': 20, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 17, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Injection site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Weight increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Syncope vasovagal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 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0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Intervertebral disc compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Acoustic neuroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Metastases to penis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Anuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 200/80', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 200/120', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG002', 'title': 'Degarelix 200/160', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG003', 'title': 'Degarelix 240/80', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG004', 'title': 'Degarelix 240/120', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG005', 'title': 'Degarelix 240/160', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '78'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '64', 'upperLimit': '95'}, {'value': '26', 'groupId': 'OG002', 'lowerLimit': '81', 'upperLimit': '100'}, {'value': '27', 'groupId': 'OG003', 'lowerLimit': '73', 'upperLimit': '98'}, {'value': '27', 'groupId': 'OG004', 'lowerLimit': '73', 'upperLimit': '98'}, {'value': '23', 'groupId': 'OG005', 'lowerLimit': '74', 'upperLimit': '99'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '61', 'ciLowerLimit': '41', 'ciUpperLimit': '78', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '84', 'ciLowerLimit': '64', 'ciUpperLimit': '95', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG002'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '96', 'ciLowerLimit': '81', 'ciUpperLimit': '100', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG003'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '90', 'ciLowerLimit': '73', 'ciUpperLimit': '98', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG004'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '90', 'ciLowerLimit': '73', 'ciUpperLimit': '98', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG005'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '92', 'ciLowerLimit': '74', 'ciUpperLimit': '99', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Number of patients who achieved a testosterone level considered a castration level.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Dose of 80 Milligram Per Cycle', 'description': 'The two treatment groups that have a maintenance dose of 80 milligram per cycle in cycles 2-13 have been combined.'}, {'id': 'OG001', 'title': 'Maintenance Dose of 120 Milligram Per Cycle', 'description': 'The two treatment groups that have a maintenance dose of 120 milligram per cycle in cycles 2-13 have been combined.'}, {'id': 'OG002', 'title': 'Maintenance Dose of 160 Milligram Per Cycle', 'description': 'The two treatment groups that have a maintenance dose of 160 milligram per cycle in cycles 2-13 have been combined.'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '98'}, {'value': '48', 'groupId': 'OG001', 'lowerLimit': '86', 'upperLimit': '100'}, {'value': '49', 'groupId': 'OG002', 'lowerLimit': '93', 'upperLimit': '100'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '92', 'ciLowerLimit': '80', 'ciUpperLimit': '98', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone (T) \\<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \\<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '96', 'ciLowerLimit': '86', 'ciUpperLimit': '100', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone (T) \\<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \\<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG002'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '100', 'ciLowerLimit': '93', 'ciUpperLimit': '100', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone (T) \\<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \\<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 - 364', 'description': 'Number of patients who maintained a castration level of testosterone (\\<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population of patients with testoterone measurements \\<=0.5 nanogram/milliliter at Day 28.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 200/80', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 200/120', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG002', 'title': 'Degarelix 200/160', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG003', 'title': 'Degarelix 240/80', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG004', 'title': 'Degarelix 240/120', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG005', 'title': 'Degarelix 240/160', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '51', 'upperLimit': '85'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '98'}, {'value': '31', 'groupId': 'OG002', 'lowerLimit': '84', 'upperLimit': '100'}, {'value': '29', 'groupId': 'OG003', 'lowerLimit': '83', 'upperLimit': '100'}, {'value': '31', 'groupId': 'OG004', 'lowerLimit': '80', 'upperLimit': '99'}, {'value': '27', 'groupId': 'OG005', 'lowerLimit': '77', 'upperLimit': '99'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '70', 'ciLowerLimit': '51', 'ciUpperLimit': '85', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '91', 'ciLowerLimit': '75', 'ciUpperLimit': '98', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG002'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '97', 'ciLowerLimit': '84', 'ciUpperLimit': '100', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG003'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '97', 'ciLowerLimit': '83', 'ciUpperLimit': '100', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG004'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '94', 'ciLowerLimit': '80', 'ciUpperLimit': '99', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG005'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '93', 'ciLowerLimit': '77', 'ciUpperLimit': '99', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'The number of patients who achieved the \\<=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 200/80', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 200/120', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG002', 'title': 'Degarelix 200/160', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG003', 'title': 'Degarelix 240/80', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG004', 'title': 'Degarelix 240/120', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG005', 'title': 'Degarelix 240/160', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '94'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '79', 'upperLimit': '99'}, {'value': '27', 'groupId': 'OG002', 'lowerLimit': '70', 'upperLimit': '96'}, {'value': '28', 'groupId': 'OG003', 'lowerLimit': '78', 'upperLimit': '99'}, {'value': '30', 'groupId': 'OG004', 'lowerLimit': '76', 'upperLimit': '98'}, {'value': '28', 'groupId': 'OG005', 'lowerLimit': '78', 'upperLimit': '99'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '83', 'ciLowerLimit': '65', 'ciUpperLimit': '94', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '94', 'ciLowerLimit': '79', 'ciUpperLimit': '99', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG002'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '87', 'ciLowerLimit': '70', 'ciUpperLimit': '96', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG003'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '93', 'ciLowerLimit': '78', 'ciUpperLimit': '99', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG004'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '91', 'ciLowerLimit': '76', 'ciUpperLimit': '98', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG005'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '93', 'ciLowerLimit': '78', 'ciUpperLimit': '99', 'estimateComment': 'The estimated value is the percentage of patients with Testosterone \\<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 3', 'description': 'The number of patients who achieved the \\<=0.5 nanogram/milliliter level for serum testosterone after 3 days.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Days to 50 Percent Reduction in Prostate-Specific Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 200/80', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 200/120', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG002', 'title': 'Degarelix 200/160', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG003', 'title': 'Degarelix 240/80', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG004', 'title': 'Degarelix 240/120', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG005', 'title': 'Degarelix 240/160', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '224'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '84'}, {'value': '14', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '42'}, {'value': '14', 'groupId': 'OG003', 'lowerLimit': '3', 'upperLimit': '56'}, {'value': '14', 'groupId': 'OG004', 'lowerLimit': '3', 'upperLimit': '84'}, {'value': '14', 'groupId': 'OG005', 'lowerLimit': '3', 'upperLimit': '56'}]}]}], 'analyses': [{'pValue': '0.0933', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 (post dose) to Day 364', 'description': 'Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Days to 90 Percent Reduction in Prostate-Specific Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 200/80', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 200/120', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG002', 'title': 'Degarelix 200/160', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG003', 'title': 'Degarelix 240/80', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG004', 'title': 'Degarelix 240/120', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG005', 'title': 'Degarelix 240/160', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '168'}, {'value': '56', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '336'}, {'value': '56', 'groupId': 'OG002', 'lowerLimit': '14', 'upperLimit': '336'}, {'value': '56', 'groupId': 'OG003', 'lowerLimit': '14', 'upperLimit': '196'}, {'value': '56', 'groupId': 'OG004', 'lowerLimit': '28', 'upperLimit': '364'}, {'value': '56', 'groupId': 'OG005', 'lowerLimit': '14', 'upperLimit': '196'}]}]}], 'analyses': [{'pValue': '0.165', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 (post dose) to Day 364', 'description': 'Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Days to Prostate-Specific Antigen Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 200/120', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 200/160', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG002', 'title': 'Degarelix 240/80', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG003', 'title': 'Degarelix 240/120', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG004', 'title': 'Degarelix 240/160', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000', 'lowerLimit': '140', 'upperLimit': '308'}, {'value': '308', 'groupId': 'OG001', 'lowerLimit': '308', 'upperLimit': '308'}, {'value': '280', 'groupId': 'OG002', 'lowerLimit': '252', 'upperLimit': '336'}, {'value': '224', 'groupId': 'OG003', 'lowerLimit': '126', 'upperLimit': '364'}, {'value': '140', 'groupId': 'OG004', 'lowerLimit': '140', 'upperLimit': '140'}]}]}], 'analyses': [{'pValue': '0.429', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 (post dose) to Day 364', 'description': 'Median days to prostate-specific antigen increase of \\>= 50 percent and \\>=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients with PSA progression in the six groups n=0,3,1,4,4,2. Since no patients in the 200/80 group experience PSA progression the Days to progression could not be calculated.'}, {'type': 'SECONDARY', 'title': 'Median Serum Testosterone Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 200/80', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 200/120', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG002', 'title': 'Degarelix 200/160', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG003', 'title': 'Degarelix 240/80', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG004', 'title': 'Degarelix 240/120', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG005', 'title': 'Degarelix 240/160', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}], 'classes': [{'title': 'Day 0 (Baseline)', 'categories': [{'measurements': [{'value': '4.47', 'groupId': 'OG000', 'lowerLimit': '0.816', 'upperLimit': '7.1'}, {'value': '3.93', 'groupId': 'OG001', 'lowerLimit': '1.53', 'upperLimit': '9.29'}, {'value': '4.79', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '9.47'}, {'value': '4.28', 'groupId': 'OG003', 'lowerLimit': '1.4', 'upperLimit': '10.2'}, {'value': '4.07', 'groupId': 'OG004', 'lowerLimit': '2.02', 'upperLimit': '7.7'}, {'value': '3.88', 'groupId': 'OG005', 'lowerLimit': '1.69', 'upperLimit': '8.63'}]}]}, {'title': 'Day 1 (n=30,32,32,30,33,30)', 'categories': [{'measurements': [{'value': '0.654', 'groupId': 'OG000', 'lowerLimit': '0.167', 'upperLimit': '1.81'}, {'value': '0.436', 'groupId': 'OG001', 'lowerLimit': '0.207', 'upperLimit': '1.21'}, {'value': '0.465', 'groupId': 'OG002', 'lowerLimit': '0.287', 'upperLimit': '2.44'}, {'value': '0.563', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '3'}, {'value': '0.453', 'groupId': 'OG004', 'lowerLimit': '0.21', 'upperLimit': '3.32'}, {'value': '0.576', 'groupId': 'OG005', 'lowerLimit': '0.261', 'upperLimit': '1.36'}]}]}, {'title': 'Day 3 (n=30,32,31,30,33,30)', 'categories': [{'measurements': [{'value': '0.308', 'groupId': 'OG000', 'lowerLimit': '0.121', 'upperLimit': '2.81'}, {'value': '0.26', 'groupId': 'OG001', 'lowerLimit': '0.139', 'upperLimit': '0.657'}, {'value': '0.281', 'groupId': 'OG002', 'lowerLimit': '0.125', 'upperLimit': '0.64'}, {'value': '0.265', 'groupId': 'OG003', 'lowerLimit': '0.119', 'upperLimit': '0.586'}, {'value': '0.268', 'groupId': 'OG004', 'lowerLimit': '0.133', 'upperLimit': '0.912'}, {'value': '0.261', 'groupId': 'OG005', 'lowerLimit': '0.144', 'upperLimit': '1.3'}]}]}, {'title': 'Day 7 (n=30,32,32,30,33,28)', 'categories': [{'measurements': [{'value': '0.283', 'groupId': 'OG000', 'lowerLimit': '0.098', 'upperLimit': '4'}, {'value': '0.237', 'groupId': 'OG001', 'lowerLimit': '0.066', 'upperLimit': '1.43'}, {'value': '0.198', 'groupId': 'OG002', 'lowerLimit': '0.087', 'upperLimit': '0.808'}, {'value': '0.193', 'groupId': 'OG003', 'lowerLimit': '0.104', 'upperLimit': '0.549'}, {'value': '0.216', 'groupId': 'OG004', 'lowerLimit': '0.116', 'upperLimit': '1.55'}, {'value': '0.207', 'groupId': 'OG005', 'lowerLimit': '0.074', 'upperLimit': '4.66'}]}]}, {'title': 'Day 14 (n=30,32,32,30,33,29)', 'categories': [{'measurements': [{'value': '0.173', 'groupId': 'OG000', 'lowerLimit': '0.025', 'upperLimit': '4.77'}, {'value': '0.144', 'groupId': 'OG001', 'lowerLimit': '0.054', 'upperLimit': '1.62'}, {'value': '0.122', 'groupId': 'OG002', 'lowerLimit': '0.025', 'upperLimit': '0.617'}, {'value': '0.152', 'groupId': 'OG003', 'lowerLimit': '0.025', 'upperLimit': '0.641'}, {'value': '0.134', 'groupId': 'OG004', 'lowerLimit': '0.05', 'upperLimit': '0.924'}, {'value': '0.126', 'groupId': 'OG005', 'lowerLimit': '0.055', 'upperLimit': '2.67'}]}]}, {'title': 'Day 364 (n=20,23,26,28,27,23)', 'categories': [{'measurements': [{'value': '0.137', 'groupId': 'OG000', 'lowerLimit': '0.025', 'upperLimit': '1.31'}, {'value': '0.124', 'groupId': 'OG001', 'lowerLimit': '0.025', 'upperLimit': '0.53'}, {'value': '0.105', 'groupId': 'OG002', 'lowerLimit': '0.025', 'upperLimit': '0.221'}, {'value': '0.126', 'groupId': 'OG003', 'lowerLimit': '0.025', 'upperLimit': '1.31'}, {'value': '0.12', 'groupId': 'OG004', 'lowerLimit': '0.025', 'upperLimit': '0.287'}, {'value': '0.124', 'groupId': 'OG005', 'lowerLimit': '0.05', 'upperLimit': '0.371'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 (Baseline), Days 1,3,7,14, and 364', 'unitOfMeasure': 'nanogram/milliliter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Median Prostate-specific Antigen Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 200/80', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 200/120', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG002', 'title': 'Degarelix 200/160', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG003', 'title': 'Degarelix 240/80', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG004', 'title': 'Degarelix 240/120', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG005', 'title': 'Degarelix 240/160', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}], 'classes': [{'title': 'Day 0 (Baseline)', 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '332'}, {'value': '31.5', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '1730'}, {'value': '31.5', 'groupId': 'OG002', 'lowerLimit': '2.6', 'upperLimit': '901'}, {'value': '23.1', 'groupId': 'OG003', 'lowerLimit': '3.6', 'upperLimit': '586'}, {'value': '35.3', 'groupId': 'OG004', 'lowerLimit': '2.4', 'upperLimit': '1110'}, {'value': '32', 'groupId': 'OG005', 'lowerLimit': '2', 'upperLimit': '1297'}]}]}, {'title': 'Day 3 (n=29,30,28,29,33,28)', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '207'}, {'value': '29.9', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '1061'}, {'value': '27.8', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '443'}, {'value': '22.2', 'groupId': 'OG003', 'lowerLimit': '2.7', 'upperLimit': '503'}, {'value': '26.3', 'groupId': 'OG004', 'lowerLimit': '1.8', 'upperLimit': '928'}, {'value': '25.2', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '945'}]}]}, {'title': 'Day 7 (n=30,32,32,30,33,28)', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '138'}, {'value': '18.5', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '420'}, {'value': '16.5', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '234'}, {'value': '14.8', 'groupId': 'OG003', 'lowerLimit': '2.4', 'upperLimit': '339'}, {'value': '20.8', 'groupId': 'OG004', 'lowerLimit': '1.5', 'upperLimit': '611'}, {'value': '16.9', 'groupId': 'OG005', 'lowerLimit': '0.9', 'upperLimit': '476'}]}]}, {'title': 'Day 14 (n=29,31,32,29,33,28)', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '69.5'}, {'value': '10.9', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '155'}, {'value': '9.9', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '142'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '1.4', 'upperLimit': '213'}, {'value': '13.4', 'groupId': 'OG004', 'lowerLimit': '0.4', 'upperLimit': '490'}, {'value': '8.35', 'groupId': 'OG005', 'lowerLimit': '0.4', 'upperLimit': '163'}]}]}, {'title': 'Day 364 (n=20,23,26,28,27,22)', 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '5.5'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '21.2'}, {'value': '0.95', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '21.6'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '135'}, {'value': '0.8', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '48.6'}, {'value': '0.3', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '9.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 (Baseline), Days 3, 7, 14, and 364', 'unitOfMeasure': 'nanogram / milliliter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Median Values of Di-Hydrotestosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 200/80', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 200/120', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG002', 'title': 'Degarelix 200/160', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG003', 'title': 'Degarelix 240/80', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG004', 'title': 'Degarelix 240/120', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG005', 'title': 'Degarelix 240/160', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}], 'classes': [{'title': 'Day 0 (Baseline; n=25,30,26,23,23,25)', 'categories': [{'measurements': [{'value': '430', 'groupId': 'OG000', 'lowerLimit': '140', 'upperLimit': '2600'}, {'value': '330', 'groupId': 'OG001', 'lowerLimit': '94', 'upperLimit': '760'}, {'value': '310', 'groupId': 'OG002', 'lowerLimit': '170', 'upperLimit': '630'}, {'value': '330', 'groupId': 'OG003', 'lowerLimit': '20', 'upperLimit': '760'}, {'value': '350', 'groupId': 'OG004', 'lowerLimit': '160', 'upperLimit': '640'}, {'value': '290', 'groupId': 'OG005', 'lowerLimit': '160', 'upperLimit': '550'}]}]}, {'title': 'Day 1 (n=23,27,25,24,26,24)', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '320'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '54', 'upperLimit': '290'}, {'value': '110', 'groupId': 'OG002', 'lowerLimit': '44', 'upperLimit': '250'}, {'value': '130', 'groupId': 'OG003', 'lowerLimit': '30', 'upperLimit': '380'}, {'value': '110', 'groupId': 'OG004', 'lowerLimit': '60', 'upperLimit': '480'}, {'value': '115', 'groupId': 'OG005', 'lowerLimit': '49', 'upperLimit': '220'}]}]}, {'title': 'Day 3 (n=23,27,25,25,27,25)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '150'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '130'}, {'value': '70', 'groupId': 'OG002', 'lowerLimit': '22', 'upperLimit': '130'}, {'value': '66', 'groupId': 'OG003', 'lowerLimit': '25', 'upperLimit': '180'}, {'value': '73', 'groupId': 'OG004', 'lowerLimit': '10', 'upperLimit': '190'}, {'value': '67', 'groupId': 'OG005', 'lowerLimit': '10', 'upperLimit': '180'}]}]}, {'title': 'Day 7 (n=26,30,24,26,30,22)', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '260'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '31', 'upperLimit': '220'}, {'value': '61.5', 'groupId': 'OG002', 'lowerLimit': '22', 'upperLimit': '150'}, {'value': '56.5', 'groupId': 'OG003', 'lowerLimit': '21', 'upperLimit': '130'}, {'value': '61', 'groupId': 'OG004', 'lowerLimit': '20', 'upperLimit': '240'}, {'value': '77.5', 'groupId': 'OG005', 'lowerLimit': '20', 'upperLimit': '240'}]}]}, {'title': 'Day 14 (n=19,27,25,23,25,27)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '440'}, {'value': '51', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '120'}, {'value': '42', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '110'}, {'value': '57', 'groupId': 'OG003', 'lowerLimit': '10', 'upperLimit': '110'}, {'value': '59', 'groupId': 'OG004', 'lowerLimit': '10', 'upperLimit': '130'}, {'value': '53', 'groupId': 'OG005', 'lowerLimit': '32', 'upperLimit': '250'}]}]}, {'title': 'Day 364 (n=17,21,20,25,25,21)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '79'}, {'value': '39', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '73'}, {'value': '34', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '72'}, {'value': '40', 'groupId': 'OG003', 'lowerLimit': '10', 'upperLimit': '120'}, {'value': '39', 'groupId': 'OG004', 'lowerLimit': '10', 'upperLimit': '210'}, {'value': '40', 'groupId': 'OG005', 'lowerLimit': '10', 'upperLimit': '130'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 (Baseline), Days 1, 3, 7, 14, and 364', 'unitOfMeasure': 'picogram / milliliter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Median Values for Serum Luteinizing Hormone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 200/80', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 200/120', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG002', 'title': 'Degarelix 200/160', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG003', 'title': 'Degarelix 240/80', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG004', 'title': 'Degarelix 240/120', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG005', 'title': 'Degarelix 240/160', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}], 'classes': [{'title': 'Day 0 (Baseline)', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '9.6'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '15'}, {'value': '5.05', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '27.6'}, {'value': '5.6', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '18'}, {'value': '3.9', 'groupId': 'OG004', 'lowerLimit': '1.6', 'upperLimit': '25.9'}, {'value': '6', 'groupId': 'OG005', 'lowerLimit': '1.6', 'upperLimit': '19.5'}]}]}, {'title': 'Day 1 (n=28,30,32,28,31,30)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '5.7'}, {'value': '0.65', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '3.4'}, {'value': '0.7', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '4.6'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '5.8'}, {'value': '0.7', 'groupId': 'OG004', 'lowerLimit': '0.3', 'upperLimit': '7.2'}, {'value': '0.75', 'groupId': 'OG005', 'lowerLimit': '0.4', 'upperLimit': '4.6'}]}]}, {'title': 'Day 3 (n=29,30,28,29,33,28)', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.7'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '1.9'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '2.1'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '1.3'}, {'value': '0.4', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '2.4'}, {'value': '0.55', 'groupId': 'OG005', 'lowerLimit': '0.2', 'upperLimit': '1.8'}]}]}, {'title': 'Day 7 (n=30,32,32,30,33,28)', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '5.7'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.5'}, {'value': '0.6', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '3.4'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '0.05', 'upperLimit': '3.4'}, {'value': '0.5', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '2.5'}, {'value': '0.75', 'groupId': 'OG005', 'lowerLimit': '0.2', 'upperLimit': '4.3'}]}]}, {'title': 'Day 14 (n=29,31,32,29,33,28)', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '7.4'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.8'}, {'value': '0.35', 'groupId': 'OG002', 'lowerLimit': '0.05', 'upperLimit': '4.5'}, {'value': '0.3', 'groupId': 'OG003', 'lowerLimit': '0.05', 'upperLimit': '5.1'}, {'value': '0.3', 'groupId': 'OG004', 'lowerLimit': '0.05', 'upperLimit': '1.8'}, {'value': '0.3', 'groupId': 'OG005', 'lowerLimit': '0.05', 'upperLimit': '4.8'}]}]}, {'title': 'Day 364 (n=20,23,26,28,27,22)', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '1.5'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '2.3'}, {'value': '0.2', 'groupId': 'OG002', 'lowerLimit': '0.05', 'upperLimit': '0.6'}, {'value': '0.4', 'groupId': 'OG003', 'lowerLimit': '0.05', 'upperLimit': '2.5'}, {'value': '0.2', 'groupId': 'OG004', 'lowerLimit': '0.05', 'upperLimit': '0.8'}, {'value': '0.3', 'groupId': 'OG005', 'lowerLimit': '0.05', 'upperLimit': '1.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 (Baseline), Days 1, 3, 7, 14, and 364', 'unitOfMeasure': 'international units / liter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Median Values for Follicle Stimulation Hormone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 200/80', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 200/120', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG002', 'title': 'Degarelix 200/160', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG003', 'title': 'Degarelix 240/80', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG004', 'title': 'Degarelix 240/120', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG005', 'title': 'Degarelix 240/160', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}], 'classes': [{'title': 'Day 0 (Baseline)', 'categories': [{'measurements': [{'value': '8.35', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '45.4'}, {'value': '9.25', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '39.2'}, {'value': '9', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '40.7'}, {'value': '9.7', 'groupId': 'OG003', 'lowerLimit': '4.1', 'upperLimit': '61.7'}, {'value': '7', 'groupId': 'OG004', 'lowerLimit': '2.3', 'upperLimit': '76.1'}, {'value': '10.2', 'groupId': 'OG005', 'lowerLimit': '1.8', 'upperLimit': '67.9'}]}]}, {'title': 'Day 1 (n=28,30,32,28,31,30)', 'categories': [{'measurements': [{'value': '5.15', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '28.6'}, {'value': '5.65', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '24.8'}, {'value': '5.35', 'groupId': 'OG002', 'lowerLimit': '2.3', 'upperLimit': '24.8'}, {'value': '6.2', 'groupId': 'OG003', 'lowerLimit': '2.4', 'upperLimit': '46.2'}, {'value': '4.4', 'groupId': 'OG004', 'lowerLimit': '1.7', 'upperLimit': '55.2'}, {'value': '5.9', 'groupId': 'OG005', 'lowerLimit': '1', 'upperLimit': '47.4'}]}]}, {'title': 'Day 3 (n=29,30,28,29,33,28)', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '14.4'}, {'value': '3.15', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '14.1'}, {'value': '3.25', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '13.5'}, {'value': '3.3', 'groupId': 'OG003', 'lowerLimit': '1.4', 'upperLimit': '9.3'}, {'value': '2.5', 'groupId': 'OG004', 'lowerLimit': '0.9', 'upperLimit': '31.5'}, {'value': '3.1', 'groupId': 'OG005', 'lowerLimit': '0.7', 'upperLimit': '24.1'}]}]}, {'title': 'Day 7 (n=30,32,32,30,33,28)', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '9.3'}, {'value': '1.95', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '12.9'}, {'value': '1.85', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '8.7'}, {'value': '1.85', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '16'}, {'value': '1.4', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '16.1'}, {'value': '2.55', 'groupId': 'OG005', 'lowerLimit': '0.6', 'upperLimit': '13.1'}]}]}, {'title': 'Day 14 (n=29,31,32,29,33,28)', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '11.5'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '11.2'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '7.9'}, {'value': '0.8', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '8.5'}, {'value': '0.7', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '8'}, {'value': '0.95', 'groupId': 'OG005', 'lowerLimit': '0.2', 'upperLimit': '14.5'}]}]}, {'title': 'Day 364 (n=20,23,26,28,27,22)', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '7'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '7.6'}, {'value': '1.45', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '6.4'}, {'value': '1.75', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '13'}, {'value': '1.1', 'groupId': 'OG004', 'lowerLimit': '0.3', 'upperLimit': '5.3'}, {'value': '2.2', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '11.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 (Baseline), Days 1, 3, 7, 14, and 364', 'unitOfMeasure': 'international units / liter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'The Number of Patients With Abnormal Liver Function Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 200/80', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 200/120', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG002', 'title': 'Degarelix 200/160', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG003', 'title': 'Degarelix 240/80', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG004', 'title': 'Degarelix 240/120', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG005', 'title': 'Degarelix 240/160', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}], 'classes': [{'title': 'Abnormal alanine aminotransferase (ALT)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}]}, {'title': 'Abnormal aspartate aminotransferase', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}]}, {'title': 'Abnormal bilirubin', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'ALT >3x ULN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}, {'title': 'ALT>3x ULN and bilirubin >1.5x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '364 days', 'description': 'The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases \\>3x ULN, and patients with ALT increases \\>3x ULN with concurrent increases in bilirubin \\>1.5 ULN.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 200/80', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG001', 'title': 'Degarelix 200/120', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG002', 'title': 'Degarelix 200/160', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG003', 'title': 'Degarelix 240/80', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG004', 'title': 'Degarelix 240/120', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'OG005', 'title': 'Degarelix 240/160', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}], 'classes': [{'title': 'Diastolic blood pressure <=50 and decrease >=15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Diastolic blood pressure >=105 and increase >=15', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Pulse <=50 and decrease >=15 from baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Pulse >=120 and increase of >=15 from baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Systolic blood pressure <=90 and decrease >=20', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Systolic blood pressure >=180 and increase >=20', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Weight decrease of >=7% from baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Weight increase of >=7% from baseline', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 364', 'description': 'Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Degarelix 200/80', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'FG001', 'title': 'Degarelix 200/120', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'FG002', 'title': 'Degarelix 200/160', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'FG003', 'title': 'Degarelix 240/80', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'FG004', 'title': 'Degarelix 240/120', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'FG005', 'title': 'Degarelix 240/160', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '33'}, {'groupId': 'FG005', 'numSubjects': '31'}]}, {'type': 'Randomised and Treated (ITT Population)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '33'}, {'groupId': 'FG005', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '27'}, {'groupId': 'FG005', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Testosterone >1ng/ml from Day 28+', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Testosterone >=.5ng/ml 2 visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Prostate-specific antigen progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Two hundred and sixteen patients were screened. Twenty-seven were screening failures. Two randomized patients were not treated: one withdrew consent and the other had an elevated alanine aminotransferase value (an exclusion criteria found after randomization).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '187', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Degarelix 200/80', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'BG001', 'title': 'Degarelix 200/120', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'BG002', 'title': 'Degarelix 200/160', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'BG003', 'title': 'Degarelix 240/80', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'BG004', 'title': 'Degarelix 240/120', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'BG005', 'title': 'Degarelix 240/160', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '37', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '150', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.9', 'spread': '8.27', 'groupId': 'BG000'}, {'value': '70.6', 'spread': '7.72', 'groupId': 'BG001'}, {'value': '73.3', 'spread': '7.39', 'groupId': 'BG002'}, {'value': '70.4', 'spread': '7.07', 'groupId': 'BG003'}, {'value': '70.7', 'spread': '7.56', 'groupId': 'BG004'}, {'value': '70.7', 'spread': '8.59', 'groupId': 'BG005'}, {'value': '70.9', 'spread': '7.75', 'groupId': 'BG006'}]}]}], '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'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '187', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '180', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Patients at Each Stage of Prostate Cancer', 'classes': [{'title': 'Localized', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}]}]}, {'title': 'Locally advanced', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '60', 'groupId': 'BG006'}]}]}, {'title': 'Metastatic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}]}]}, {'title': 'Not classifiable', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '50', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'description': 'Prostate cancer stage was classified to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tummors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.', 'unitOfMeasure': 'patients'}, {'title': 'Patient Counts by Gleason Score', 'classes': [{'title': 'unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': '2-4', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}]}]}, {'title': '5-6', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '76', 'groupId': 'BG006'}]}]}, {'title': '7-10', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '73', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'description': 'The Gleason Score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10 with low numbers being the least aggressive and 10 being the most aggressive.', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'spread': '3.5', 'groupId': 'BG000', 'lowerLimit': '18.1', 'upperLimit': '36'}, {'value': '26.4', 'spread': '3.74', 'groupId': 'BG001', 'lowerLimit': '20.3', 'upperLimit': '36.8'}, {'value': '25.9', 'spread': '4.46', 'groupId': 'BG002', 'lowerLimit': '17.9', 'upperLimit': '36.3'}, {'value': '27.7', 'spread': '5.3', 'groupId': 'BG003', 'lowerLimit': '18.5', 'upperLimit': '41.1'}, {'value': '26', 'spread': '3.28', 'groupId': 'BG004', 'lowerLimit': '18.2', 'upperLimit': '32.7'}, {'value': '25.3', 'spread': '2.73', 'groupId': 'BG005', 'lowerLimit': '20.3', 'upperLimit': '29.8'}, {'value': '26.3', 'spread': '3.94', 'groupId': 'BG006', 'lowerLimit': '17.9', 'upperLimit': '41.1'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index is a measure of body fat based on height and weight.', 'unitOfMeasure': 'kilograms per square meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Days Since Diagnosis of Prostate Cancer', 'classes': [{'categories': [{'measurements': [{'value': '493', 'spread': '849', 'groupId': 'BG000'}, {'value': '122', 'spread': '230', 'groupId': 'BG001'}, {'value': '375', 'spread': '1098', 'groupId': 'BG002'}, {'value': '383', 'spread': '817', 'groupId': 'BG003'}, {'value': '229', 'spread': '508', 'groupId': 'BG004'}, {'value': '352', 'spread': '743', 'groupId': 'BG005'}, {'value': '323', 'spread': '756', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'The mean number of days that have passed since a diagnosis of prostate cancer was made for each patient.', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Median Serum Testosterone Level', 'classes': [{'categories': [{'measurements': [{'value': '4.47', 'groupId': 'BG000', 'lowerLimit': '0.816', 'upperLimit': '7.1'}, {'value': '3.93', 'groupId': 'BG001', 'lowerLimit': '1.53', 'upperLimit': '9.29'}, {'value': '4.79', 'groupId': 'BG002', 'lowerLimit': '2.8', 'upperLimit': '9.47'}, {'value': '4.28', 'groupId': 'BG003', 'lowerLimit': '1.4', 'upperLimit': '10.2'}, {'value': '4.07', 'groupId': 'BG004', 'lowerLimit': '2.02', 'upperLimit': '7.7'}, {'value': '3.88', 'groupId': 'BG005', 'lowerLimit': '1.69', 'upperLimit': '8.63'}, {'value': '4.13', 'groupId': 'BG006', 'lowerLimit': '0.816', 'upperLimit': '10.2'}]}]}], 'paramType': 'MEDIAN', 'description': 'Testosterone is a steroid hormone from the androgen group, and the principal male sex hormone. This test measures the amount of testosterone in the blood. Androgen deprivation is used to manage prostate cancer.', 'unitOfMeasure': 'nanogram / milliliter', 'dispersionType': 'FULL_RANGE'}, {'title': 'Serum Prostate-specific Antigen', 'classes': [{'categories': [{'measurements': [{'value': '15.2', 'groupId': 'BG000', 'lowerLimit': '2.6', 'upperLimit': '332'}, {'value': '31.5', 'groupId': 'BG001', 'lowerLimit': '3.3', 'upperLimit': '1730'}, {'value': '31.5', 'groupId': 'BG002', 'lowerLimit': '2.6', 'upperLimit': '901'}, {'value': '23.1', 'groupId': 'BG003', 'lowerLimit': '3.6', 'upperLimit': '586'}, {'value': '35.3', 'groupId': 'BG004', 'lowerLimit': '2.4', 'upperLimit': '1110'}, {'value': '32', 'groupId': 'BG005', 'lowerLimit': '2', 'upperLimit': '1297'}, {'value': '27.6', 'groupId': 'BG006', 'lowerLimit': '2', 'upperLimit': '1730'}]}]}], 'paramType': 'MEDIAN', 'description': 'Prostate-specific antigen (PSA) is a protein produced by the cells of the prostate gland. The PSA test measures the level of PSA in the blood. High PSA levels have a positive correlation to prostate cancer.', 'unitOfMeasure': 'nanogram / milliliter', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2009-01-07', 'resultsFirstSubmitDate': '2009-01-22', 'studyFirstSubmitQcDate': '2009-01-07', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-03-30', 'studyFirstPostDateStruct': {'date': '2009-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364', 'timeFrame': '12 months', 'description': 'Number of patients who achieved a testosterone level considered a castration level.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28', 'timeFrame': 'Day 28 - 364', 'description': 'Number of patients who maintained a castration level of testosterone (\\<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.'}, {'measure': 'Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.', 'timeFrame': 'Day 28', 'description': 'The number of patients who achieved the \\<=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.'}, {'measure': 'Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.', 'timeFrame': 'Day 3', 'description': 'The number of patients who achieved the \\<=0.5 nanogram/milliliter level for serum testosterone after 3 days.'}, {'measure': 'Days to 50 Percent Reduction in Prostate-Specific Antigen', 'timeFrame': 'Day 0 (post dose) to Day 364', 'description': 'Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.'}, {'measure': 'Days to 90 Percent Reduction in Prostate-Specific Antigen', 'timeFrame': 'Day 0 (post dose) to Day 364', 'description': 'Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.'}, {'measure': 'Days to Prostate-Specific Antigen Progression', 'timeFrame': 'Day 0 (post dose) to Day 364', 'description': 'Median days to prostate-specific antigen increase of \\>= 50 percent and \\>=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.'}, {'measure': 'Median Serum Testosterone Levels', 'timeFrame': 'Day 0 (Baseline), Days 1,3,7,14, and 364'}, {'measure': 'Median Prostate-specific Antigen Levels', 'timeFrame': 'Day 0 (Baseline), Days 3, 7, 14, and 364'}, {'measure': 'Median Values of Di-Hydrotestosterone', 'timeFrame': 'Day 0 (Baseline), Days 1, 3, 7, 14, and 364'}, {'measure': 'Median Values for Serum Luteinizing Hormone', 'timeFrame': 'Day 0 (Baseline), Days 1, 3, 7, 14, and 364'}, {'measure': 'Median Values for Follicle Stimulation Hormone', 'timeFrame': 'Day 0 (Baseline), Days 1, 3, 7, 14, and 364'}, {'measure': 'The Number of Patients With Abnormal Liver Function Tests', 'timeFrame': '364 days', 'description': 'The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases \\>3x ULN, and patients with ALT increases \\>3x ULN with concurrent increases in bilirubin \\>1.5 ULN.'}, {'measure': 'The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight', 'timeFrame': 'Day 364', 'description': 'Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '18538469', 'type': 'RESULT', 'citation': 'Van Poppel H, Tombal B, de la Rosette JJ, Persson BE, Jensen JK, Kold Olesen T. Degarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker--results from a 1-yr, multicentre, randomised, phase 2 dosage-finding study in the treatment of prostate cancer. Eur Urol. 2008 Oct;54(4):805-13. doi: 10.1016/j.eururo.2008.04.065. Epub 2008 May 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a year. During the treatment the patients had to visit the clinic for investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed throughout the trial.', 'detailedDescription': 'Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent prior to any study related procedures\n* Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy\n* ECOG score to be equal to or above 2\n* Testosterone level within age-specific normal range\n* PSA value equal to or above 2 ng/ml\n* Life expectancy of at least 6 months\n\nExclusion Criteria:\n\n* Previous or current hormonal treatment of prostate cancer\n* Recent or current treatment with any drugs modifying the testosterone level\n* Candidate for curative treatment such as prostatectomy or radiotherapy\n* History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or Quincke's Oedema\n* Hypersensitivity towards any component of degarelix or mannitol\n* Cancer disease within the last 5 years except for prostate cancer and some skin cancers\n* Signs of liver impairment shown as elevated serum ALT or serum bilirubin\n* Known hepatic disease\n* Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results\n* Clinically significant disorder including excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator\n* Mental incapacity or language barrier precluding adequate understanding or cooperation\n* Having received an investigational product within the last 12 weeks preceding the trial\n* Previous participation in this trial"}, 'identificationModule': {'nctId': 'NCT00819156', 'briefTitle': 'Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'An Open-label, Randomised, Multi-centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients With Prostate Cancer Treated for 12 Months', 'orgStudyIdInfo': {'id': 'FE200486 CS12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Degarelix 200/80', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.', 'interventionNames': ['Drug: degarelix']}, {'type': 'EXPERIMENTAL', 'label': 'Degarelix 200/120', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.', 'interventionNames': ['Drug: degarelix']}, {'type': 'EXPERIMENTAL', 'label': 'Degarelix 200/160', 'description': 'Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.', 'interventionNames': ['Drug: degarelix']}, {'type': 'EXPERIMENTAL', 'label': 'Degarelix 240/80', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.', 'interventionNames': ['Drug: degarelix']}, {'type': 'EXPERIMENTAL', 'label': 'Degarelix 240/120', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.', 'interventionNames': ['Drug: degarelix']}, {'type': 'EXPERIMENTAL', 'label': 'Degarelix 240/160', 'description': 'Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.', 'interventionNames': ['Drug: degarelix']}], 'interventions': [{'name': 'degarelix', 'type': 'DRUG', 'otherNames': ['FE200486'], 'description': 'Degarelix was given as subcutaneous injections.', 'armGroupLabels': ['Degarelix 200/120', 'Degarelix 200/160', 'Degarelix 200/80', 'Degarelix 240/120', 'Degarelix 240/160', 'Degarelix 240/80']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'UCL Saint Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Vivantes Klinikum am Urban', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Loretto Krankenhaus', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Fürth', 'country': 'Germany', 'facility': 'Euromed AG Klinik', 'geoPoint': {'lat': 49.47593, 'lon': 10.98856}}, {'city': 'Mannheim', 'country': 'Germany', 'facility': 'Urologische Universitätsklinikum', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Bajcsy-Zsilinszky Hospital, Urology', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Jahn Ferenc Dél Pesti Hospital, Urology', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Győr', 'country': 'Hungary', 'facility': 'Pez Aladar County Hospital', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'city': 'Miskolc', 'country': 'Hungary', 'facility': 'BAZ County Hospital', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'city': 'Szeged', 'country': 'Hungary', 'facility': 'Hospital of Local Gov. Szeged, Urology', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'city': 'Szolnok', 'country': 'Hungary', 'facility': 'MÁV Hospital, Urology', 'geoPoint': {'lat': 47.18066, 'lon': 20.19835}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Atrium MC', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'city': 'Siedlce', 'country': 'Poland', 'facility': 'Wojewódzki Szpital Specjalisttyczny', 'geoPoint': {'lat': 52.16772, 'lon': 22.29006}}, {'city': 'Słupsk', 'country': 'Poland', 'facility': 'Wojewódzki Szpital Specjalisttyczny', 'geoPoint': {'lat': 54.46405, 'lon': 17.02872}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'CF2 Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Dr. Th Burghele Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Fundeni Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Sf. Ioan Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Botkin Clinical Hospital', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'City Hospital #1', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'City Hospital #29', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'City Hospital #50', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'City Hospital #60', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Institute of Urology of MoH', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': '"Andros" Urology Clinic', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Hospital #15', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Hospital #26', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Military Medical Academy, Urology', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Pavlov Medical School Outpatient', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Pavlov medical School, Urology', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Sct Petersburg State Medical Academy', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Glenwood, Durban', 'country': 'South Africa', 'facility': '370 Clarke Road'}, {'city': 'Hatfield, Pretoria', 'country': 'South Africa', 'facility': 'Pretoria Urology Hospital'}, {'city': 'Parktown', 'country': 'South Africa', 'facility': 'WITS Medical School', 'geoPoint': {'lat': -26.18205, 'lon': 28.02671}}, {'city': 'Pietermaritzburg', 'country': 'South Africa', 'facility': '401B Medical Centre', 'geoPoint': {'lat': -29.61679, 'lon': 30.39278}}, {'city': 'Sunninghill', 'country': 'South Africa', 'facility': 'Sunninghill Clinic', 'geoPoint': {'lat': -26.0355, 'lon': 28.06552}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}