Viewing Study NCT00215657

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Ignite Creation Date: 2025-12-24 @ 6:32 PM
Ignite Modification Date: 2026-02-25 @ 10:05 PM
Study NCT ID: NCT00215657
Status: TERMINATED
Last Update Posted: 2011-05-20
First Post: 2005-09-20
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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': 'Ferring Pharmaceuticals', 'organization': 'Clinical Development Support'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Degarelix 120mg (20mg/mL)', 'description': 'Degarelix 120 mg (20 mg/mL)', 'otherNumAffected': 18, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Degarelix 120mg (40mg/mL)', 'description': 'Degarelix 120 mg (40 mg/mL)', 'otherNumAffected': 10, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Degarelix 160mg (40mg/mL)', 'description': 'Degarelix 160 mg (40 mg/mL)', 'otherNumAffected': 9, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Degarelix 200mg (40mg/mL)', 'description': 'Degarelix 200 mg (40 mg/mL)', 'otherNumAffected': 24, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': 'Degarelix 200mg (60mg/mL)', 'description': 'Degarelix 200 mg (60 mg/mL)', 'otherNumAffected': 17, 'seriousNumAffected': 8}, {'id': 'EG005', 'title': 'Degarelix 240mg (40mg/mL)', 'description': 'Degarelix 240 mg (40 mg/mL)', 'otherNumAffected': 22, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'Degarelix 240mg (60mg/mL)', 'description': 'Degarelix 240 mg (60 mg/mL)', 'otherNumAffected': 12, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Degarelix 320mg (60mg/mL)', 'description': 'Degarelix 320 mg (60 mg/mL)', 'otherNumAffected': 19, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Arrhytmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 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'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Areflexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Paraplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Amputation revision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Liver Function Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 120mg (20mg/mL)', 'description': 'Degarelix 120 mg (20 mg/mL)'}, {'id': 'OG001', 'title': 'Degarelix 120mg (40mg/mL)', 'description': 'Degarelix 120 mg (40 mg/mL)'}, {'id': 'OG002', 'title': 'Degarelix 160mg (40mg/mL)', 'description': 'Degarelix 160 mg (40 mg/mL)'}, {'id': 'OG003', 'title': 'Degarelix 200mg (40mg/mL)', 'description': 'Degarelix 200 mg (40 mg/mL)'}, {'id': 'OG004', 'title': 'Degarelix 200mg (60mg/mL)', 'description': 'Degarelix 200 mg (60 mg/mL)'}, {'id': 'OG005', 'title': 'Degarelix 240mg (40mg/mL)', 'description': 'Degarelix 240 mg (40 mg/mL)'}, {'id': 'OG006', 'title': 'Degarelix 240mg (60mg/mL)', 'description': 'Degarelix 240 mg (60 mg/mL)'}, {'id': 'OG007', 'title': 'Degarelix 320mg (60mg/mL)', 'description': 'Degarelix 320 mg (60 mg/mL)'}], 'classes': [{'title': 'Abnormal alanine aminotransferase (ALAT)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}]}]}, {'title': 'Abnormal aspartate aminotransferase', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}]}, {'title': 'Abnormal bilirubin', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'ALAT >3x ULN', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'ALAT >3x ULN, bilirubin >2x ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \\>3x ULN and ALT increases \\>3x ULN with concurrently increased bilirubin \\>1.5 ULN.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data include patients from both the main study (FE200486 CS07) and the extension study FE200486 CS07A'}, {'type': 'PRIMARY', 'title': 'Participants With Markedly Abnormal Change in Vital Signs and Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 120mg (20mg/mL)', 'description': 'Degarelix 120 mg (20 mg/mL)'}, {'id': 'OG001', 'title': 'Degarelix 120mg (40mg/mL)', 'description': 'Degarelix 120 mg (40 mg/mL)'}, {'id': 'OG002', 'title': 'Degarelix 160mg (40mg/mL)', 'description': 'Degarelix 160 mg (40 mg/mL)'}, {'id': 'OG003', 'title': 'Degarelix 200mg (40mg/mL)', 'description': 'Degarelix 200 mg (40 mg/mL)'}, {'id': 'OG004', 'title': 'Degarelix 200mg (60mg/mL)', 'description': 'Degarelix 200 mg (60 mg/mL)'}, {'id': 'OG005', 'title': 'Degarelix 240mg (40mg/mL)', 'description': 'Degarelix 240 mg (40 mg/mL)'}, {'id': 'OG006', 'title': 'Degarelix 240mg (60mg/mL)', 'description': 'Degarelix 240 mg (60 mg/mL)'}, {'id': 'OG007', 'title': 'Degarelix 320mg (60mg/mL)', 'description': 'Degarelix 320 mg (60 mg/mL)'}], 'classes': [{'title': 'Diastolic blood pressure <=50 and decrease >=15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Diastolic blood pressure >=105 and increase >=15', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Systolic blood pressure <=90 and decrease >=20', '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'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Systolic blood pressure >=180 and increase >=20', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Heart rate <=50 and decrease >=15', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Heart rate >=120 and increase >=15', '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'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Body weight decrease of >=7 percent', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Body weight increase of >=7 percent', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'These data include patients from the main study (FE200486 CS07) and the extension study (FE200486 CS07A).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Degarelix 120mg (20mg/mL)', 'description': 'Degarelix 120 mg (20 mg/mL)'}, {'id': 'FG001', 'title': 'Degarelix 120mg (40mg/mL)', 'description': 'Degarelix 120 mg (40 mg/mL)'}, {'id': 'FG002', 'title': 'Degarelix 160mg (40mg/mL)', 'description': 'Degarelix 160 mg (40 mg/mL)'}, {'id': 'FG003', 'title': 'Degarelix 200mg (40mg/mL)', 'description': 'Degarelix 200 mg (40 mg/mL)'}, {'id': 'FG004', 'title': 'Degarelix 200mg (60mg/mL)', 'description': 'Degarelix 200 mg (60 mg/mL)'}, {'id': 'FG005', 'title': 'Degarelix 240mg (40mg/mL)', 'description': 'Degarelix 240 mg (40 mg/mL)'}, {'id': 'FG006', 'title': 'Degarelix 240mg (60mg/mL)', 'description': 'Degarelix 240 mg (60 mg/mL)'}, {'id': 'FG007', 'title': 'Degarelix 320mg (60mg/mL)', 'description': 'Degarelix 320 mg (60 mg/mL)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '27'}, {'groupId': 'FG005', 'numSubjects': '24'}, {'groupId': 'FG006', 'numSubjects': '27'}, {'groupId': 'FG007', 'numSubjects': '27'}]}, {'type': 'Intention-to-treat Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '24'}, {'groupId': 'FG005', 'numSubjects': '24'}, {'groupId': 'FG006', 'numSubjects': '24'}, {'groupId': 'FG007', 'numSubjects': '27'}]}, {'type': 'Started FE200486 CS07A', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '20'}, {'groupId': 'FG006', 'numSubjects': '14'}, {'groupId': 'FG007', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants ongoing at the time of study closure were considered to have completed the study.', 'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '23'}, {'groupId': 'FG005', 'numSubjects': '20'}, {'groupId': 'FG006', 'numSubjects': '23'}, {'groupId': 'FG007', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'Insuff prostate specific antigen resp', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'Insufficient testosterone response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '7'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants who responded to degarelix in FE200486 CS07 (NCT00818623) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available or until the study was discontinued. Participants received the same dose of degarelix as they received in FE200486 CS07.', 'preAssignmentDetails': '180 participants started the main study CS07 and 172 participants received degarelix treatment (intention-to-treat population). Of these, 131 participants were recruited into the extension study CS07A'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '27', 'groupId': 'BG007'}, {'value': '172', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Degarelix 120mg (20mg/mL)', 'description': 'Degarelix 120 mg (20 mg/mL)'}, {'id': 'BG001', 'title': 'Degarelix 120mg (40mg/mL)', 'description': 'Degarelix 120 mg (40 mg/mL)'}, {'id': 'BG002', 'title': 'Degarelix 160mg (40mg/mL)', 'description': 'Degarelix 160 mg (40 mg/mL)'}, {'id': 'BG003', 'title': 'Degarelix 200mg (40mg/mL)', 'description': 'Degarelix 200 mg (40 mg/mL)'}, {'id': 'BG004', 'title': 'Degarelix 200mg (60mg/mL)', 'description': 'Degarelix 200 mg (60 mg/mL)'}, {'id': 'BG005', 'title': 'Degarelix 240mg (40mg/mL)', 'description': 'Degarelix 240 mg (40 mg/mL)'}, {'id': 'BG006', 'title': 'Degarelix 240mg (60mg/mL)', 'description': 'Degarelix 240 mg (60 mg/mL)'}, {'id': 'BG007', 'title': 'Degarelix 320mg (60mg/mL)', 'description': 'Degarelix 320 mg (60 mg/mL)'}, {'id': 'BG008', '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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '29', 'groupId': 'BG008'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '143', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Intention-to-treat (ITT) population.', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.0', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '73.8', 'spread': '3.97', 'groupId': 'BG001'}, {'value': '70.1', 'spread': '8.08', 'groupId': 'BG002'}, {'value': '74.3', 'spread': '6.48', 'groupId': 'BG003'}, {'value': '71.5', 'spread': '8.27', 'groupId': 'BG004'}, {'value': '73.1', 'spread': '5.96', 'groupId': 'BG005'}, {'value': '71.7', 'spread': '9.54', 'groupId': 'BG006'}, {'value': '71.1', 'spread': '6.87', 'groupId': 'BG007'}, {'value': '71.9', 'spread': '7.83', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'description': 'ITT population.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '27', 'groupId': 'BG007'}, {'value': '172', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ITT population.', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '27', 'groupId': 'BG007'}, {'value': '172', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'description': 'ITT population.', 'unitOfMeasure': 'participants'}, {'title': 'Curative intent', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '26', 'groupId': 'BG007'}, {'value': '165', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'description': 'ITT population. A curative intent of Yes refers to participants who have been castrated via radical prostatectomy or radiotherapy.', 'unitOfMeasure': 'participants'}, {'title': 'Gleason score', 'classes': [{'title': '2-4', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '31', 'groupId': 'BG008'}]}]}, {'title': '5-6', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '43', 'groupId': 'BG008'}]}]}, {'title': '7-10', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '98', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'description': 'ITT population. The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive.', 'unitOfMeasure': 'participants'}, {'title': 'Stage of prostate cancer', 'classes': [{'title': 'Localized', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '46', 'groupId': 'BG008'}]}]}, {'title': 'Locally advanced', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '63', 'groupId': 'BG008'}]}]}, {'title': 'Metastatic', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '52', 'groupId': 'BG008'}]}]}, {'title': 'Not classifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '11', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'description': 'ITT population. 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 tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '26.2', 'spread': '2.97', 'groupId': 'BG000'}, {'value': '26.6', 'spread': '4.58', 'groupId': 'BG001'}, {'value': '26.3', 'spread': '3.74', 'groupId': 'BG002'}, {'value': '25.9', 'spread': '2.99', 'groupId': 'BG003'}, {'value': '24.5', 'spread': '2.92', 'groupId': 'BG004'}, {'value': '26.9', 'spread': '3.18', 'groupId': 'BG005'}, {'value': '24.8', 'spread': '2.72', 'groupId': 'BG006'}, {'value': '27.1', 'spread': '3.63', 'groupId': 'BG007'}, {'value': '26.0', 'spread': '3.32', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'description': 'ITT population.', 'unitOfMeasure': 'kilogram per square meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time since prostate cancer diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '83', 'spread': '157', 'groupId': 'BG000'}, {'value': '66', 'spread': '53', 'groupId': 'BG001'}, {'value': '222', 'spread': '328', 'groupId': 'BG002'}, {'value': '146', 'spread': '298', 'groupId': 'BG003'}, {'value': '252', 'spread': '560', 'groupId': 'BG004'}, {'value': '303', 'spread': '837', 'groupId': 'BG005'}, {'value': '121', 'spread': '425', 'groupId': 'BG006'}, {'value': '47', 'spread': '54', 'groupId': 'BG007'}, {'value': '156', 'spread': '439', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'description': 'ITT population.', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '77.8', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '82.2', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '80.7', 'spread': '11.8', 'groupId': 'BG002'}, {'value': '78.2', 'spread': '13.7', 'groupId': 'BG003'}, {'value': '74.2', 'spread': '9.88', 'groupId': 'BG004'}, {'value': '81.5', 'spread': '10.7', 'groupId': 'BG005'}, {'value': '73.5', 'spread': '9.55', 'groupId': 'BG006'}, {'value': '81.7', 'spread': '11.1', 'groupId': 'BG007'}, {'value': '78.4', 'spread': '11.6', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'description': 'ITT population.', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'whyStopped': 'The doses were not effective in maintaining testosterone suppression', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-18', 'studyFirstSubmitDate': '2005-09-20', 'resultsFirstSubmitDate': '2009-01-22', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2011-05-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-04-24', 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver Function Tests', 'timeFrame': '3 years', 'description': 'The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \\>3x ULN and ALT increases \\>3x ULN with concurrently increased bilirubin \\>1.5 ULN.'}, {'measure': 'Participants With Markedly Abnormal Change in Vital Signs and Body Weight', 'timeFrame': '3 years', 'description': 'Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients', '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 (FDA regulated intervention is therefore ticked "YES").\n\nThe data include participants from both the main study (FE200486 CS07; NCT00818623) and the extension study FE200486 CS07A.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males aged 18 or over\n* Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)\n* Has completed Study FE200486 CS07\n* Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07'}, 'identificationModule': {'nctId': 'NCT00215657', 'briefTitle': 'Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients', 'orgStudyIdInfo': {'id': 'FE200486 CS07A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Degarelix 120 mg (20 mg/mL)', 'description': 'Degarelix 120 mg (20 mg/mL)', 'interventionNames': ['Drug: Degarelix']}, {'type': 'EXPERIMENTAL', 'label': 'Degarelix 120 mg (40 mg/mL)', 'description': 'Degarelix 120 mg (40 mg/mL)', 'interventionNames': ['Drug: Degarelix']}, {'type': 'EXPERIMENTAL', 'label': 'Degarelix 160 mg (40 mg/mL)', 'description': 'Degarelix 160 mg (40 mg/mL)', 'interventionNames': ['Drug: Degarelix']}, {'type': 'EXPERIMENTAL', 'label': 'Degarelix 200 mg (40 mg/mL)', 'description': 'Degarelix 200 mg (40 mg/mL)', 'interventionNames': ['Drug: Degarelix']}, {'type': 'EXPERIMENTAL', 'label': 'Degarelix 200 mg (60 mg/mL)', 'description': 'Degarelix 200 mg (60 mg/mL)', 'interventionNames': ['Drug: Degarelix']}, {'type': 'EXPERIMENTAL', 'label': 'Degarelix 240 mg (40 mg/mL)', 'description': 'Degarelix 240 mg (40 mg/mL)', 'interventionNames': ['Drug: Degarelix']}, {'type': 'EXPERIMENTAL', 'label': 'Degarelix 240 mg (60 mg/mL)', 'description': 'Degarelix 240 mg (60 mg/mL)', 'interventionNames': ['Drug: Degarelix']}, {'type': 'EXPERIMENTAL', 'label': 'Degarelix 320 mg (60 mg/mL)', 'description': 'Degarelix 320 mg (60 mg/mL)', 'interventionNames': ['Drug: Degarelix']}], 'interventions': [{'name': 'Degarelix', 'type': 'DRUG', 'otherNames': ['FE200486'], 'description': 'Degarelix 120 mg (20 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).', 'armGroupLabels': ['Degarelix 120 mg (20 mg/mL)']}, {'name': 'Degarelix', 'type': 'DRUG', 'otherNames': ['FE200486'], 'description': 'Degarelix 120 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).', 'armGroupLabels': ['Degarelix 120 mg (40 mg/mL)']}, {'name': 'Degarelix', 'type': 'DRUG', 'otherNames': ['FE200486'], 'description': 'Degarelix 160 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).', 'armGroupLabels': ['Degarelix 160 mg (40 mg/mL)']}, {'name': 'Degarelix', 'type': 'DRUG', 'otherNames': ['FE200486'], 'description': 'Degarelix 200 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).', 'armGroupLabels': ['Degarelix 200 mg (40 mg/mL)']}, {'name': 'Degarelix', 'type': 'DRUG', 'otherNames': ['FE200486'], 'description': 'Degarelix 200 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).', 'armGroupLabels': ['Degarelix 200 mg (60 mg/mL)']}, {'name': 'Degarelix', 'type': 'DRUG', 'otherNames': ['FE200486'], 'description': 'Degarelix 240 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).', 'armGroupLabels': ['Degarelix 240 mg (40 mg/mL)']}, {'name': 'Degarelix', 'type': 'DRUG', 'otherNames': ['FE200486'], 'description': 'Degarelix 240 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).', 'armGroupLabels': ['Degarelix 240 mg (60 mg/mL)']}, {'name': 'Degarelix', 'type': 'DRUG', 'otherNames': ['FE200486'], 'description': 'Degarelix 320 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).', 'armGroupLabels': ['Degarelix 320 mg (60 mg/mL)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Clinical Development Support', 'oldOrganization': 'Ferring Pharmaceuticals'}}}}