Viewing Study NCT00268892

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Ignite Creation Date: 2025-12-24 @ 3:50 PM

Ignite Modification Date: 2026-03-09 @ 10:07 AM

Study NCT ID: NCT00268892

Status: COMPLETED

Last Update Posted: 2010-12-24

First Post: 2005-12-21

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer

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': {'timeFrame': '4.5 years.', 'description': "Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.", 'eventGroups': [{'id': 'EG000', 'title': 'Degarelix 240/240@40(1-3-6-9)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).', 'otherNumAtRisk': 90, 'otherNumAffected': 72, 'seriousNumAtRisk': 90, 'seriousNumAffected': 30}, {'id': 'EG001', 'title': 'Degarelix 240/240@60(1-3-6-9)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).', 'otherNumAtRisk': 95, 'otherNumAffected': 75, 'seriousNumAtRisk': 95, 'seriousNumAffected': 24}, {'id': 'EG002', 'title': 'Degarelix 240/240@60(1-4-7-10)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).', 'otherNumAtRisk': 93, 'otherNumAffected': 69, 'seriousNumAtRisk': 93, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 55, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 64, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 36, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 29, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 32, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 31, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 20, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 22, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 26, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Injection Site Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Injection Site Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Injection Site Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Injection Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 7, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 17, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Aspartate Aminotransferase Increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 14, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 20, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 33, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 38, 'numAffected': 32}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Artrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, 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'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Throat cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cerebal infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cerebrovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': "Dementia Alzheimer's type", 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Paraplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Bladder tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Urinary bladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Stasis dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Arterial disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Arterial stenosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240/240@40(1-3-6-9)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).'}, {'id': 'OG001', 'title': 'Degarelix 240/240@60(1-3-6-9)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).'}, {'id': 'OG002', 'title': 'Degarelix 240/240@60(1-4-7-10)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).'}], 'classes': [{'title': 'Diastolic blood pressure <=50 and decrease >=15', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure >=105 and increase >=15', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure <=90 and decrease >=20', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure >=180 and increase >=20', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Heart rate <=50 and decrease >=15', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Heart rate >=120 and increase >=15', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Body weight decrease of >=7 percent', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Body weight increase of >=7 percent', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 4.5 years', 'description': 'This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data include data from participants participating in both the main study (FE200486 CS15) and the extension study FE200486 CS15A.'}, {'type': 'PRIMARY', 'title': 'Liver Function Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240/240@40(1-3-6-9)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).'}, {'id': 'OG001', 'title': 'Degarelix 240/240@60(1-3-6-9)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).'}, {'id': 'OG002', 'title': 'Degarelix 240/240@60(1-4-7-10)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).'}], 'classes': [{'title': 'Abnormal alanine aminotransferase (ALAT)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Abnormal aspartate aminotransferase', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Abnormal bilirubin', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'ALAT >3x upper limit of normal (ULN)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'ALAT >3x ULN, bilirubin >1.5x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4.5 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'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Degarelix 240/240@40(1-3-6-9)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).'}, {'id': 'FG001', 'title': 'Degarelix 240/240@60(1-3-6-9)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).'}, {'id': 'FG002', 'title': 'Degarelix 240/240@60(1-4-7-10)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '95'}, {'groupId': 'FG002', 'numSubjects': '93'}]}, {'type': 'Switched to Higher Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '68'}, {'groupId': 'FG002', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Trial Site Closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants who completed the main FE200486 CS15(NCT00113753) study (except those in US and Canada) were asked to continue into the FE200486 CS15A extension study.', 'preAssignmentDetails': '447 participants started and 374 participants completed the main CS15 study. Of these, 278 participants were recruited into the extension study CS15A and 203 participants signed the informed consent for dose shift.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '278', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Degarelix 240/240@40(1-3-6-9)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).'}, {'id': 'BG001', 'title': 'Degarelix 240/240@60(1-3-6-9)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).'}, {'id': 'BG002', 'title': 'Degarelix 240/240@60(1-4-7-10)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.7', 'spread': '6.55', 'groupId': 'BG000'}, {'value': '73.3', 'spread': '7.00', 'groupId': 'BG001'}, {'value': '71.8', 'spread': '7.05', 'groupId': 'BG002'}, {'value': '72.6', 'spread': '6.88', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Safety analysis set.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '278', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Safety analysis set.', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '264', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Safety analysis set.', 'unitOfMeasure': 'Participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '76.7', 'spread': '13.0', 'groupId': 'BG000'}, {'value': '76.9', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '76.5', 'spread': '12.8', 'groupId': 'BG002'}, {'value': '76.7', 'spread': '12.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Safety analysis set.', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '25.4', 'spread': '4.14', 'groupId': 'BG000'}, {'value': '25.8', 'spread': '3.93', 'groupId': 'BG001'}, {'value': '25.8', 'spread': '4.16', 'groupId': 'BG002'}, {'value': '25.7', 'spread': '4.07', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Safety analysis set.', 'unitOfMeasure': 'kilogram per square meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Curative Intent', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Safety analysis set. 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': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}, {'title': '5-6', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}]}]}, {'title': '7-10', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '148', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Safety analysis set. 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. A Gleason Score was missing for one participant in the Degarelix 240/240@60(1-3-6-9) group.', 'unitOfMeasure': 'participants'}, {'title': 'Stage of Prostate Cancer', 'classes': [{'title': 'Localized', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}]}, {'title': 'Locally Advanced', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}]}, {'title': 'Metastatic', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}, {'title': 'Not Classifiable', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Safety analysis set. 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': 'Time since Prostate Cancer Diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '469', 'spread': '1079', 'groupId': 'BG000'}, {'value': '347', 'spread': '824', 'groupId': 'BG001'}, {'value': '255', 'spread': '583', 'groupId': 'BG002'}, {'value': '356', 'spread': '852', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Safety analysis set.', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 278}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-08', 'studyFirstSubmitDate': '2005-12-21', 'resultsFirstSubmitDate': '2010-11-17', 'studyFirstSubmitQcDate': '2005-12-21', 'lastUpdatePostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-17', 'studyFirstPostDateStruct': {'date': '2005-12-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight', 'timeFrame': 'Baseline and up to 4.5 years', 'description': 'This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.'}, {'measure': 'Liver Function Tests', 'timeFrame': '4.5 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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Androgen ablation therapy'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this extension study was to collect long-term safety and tolerability information to support a marketing authorisation application for a three-month dosage regimen of degarelix.', 'detailedDescription': 'The data include data from the participants who participated in both the main study FE200486 CS15 (NCT00113753) and the extension study FE200486 CS15A.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has given written consent prior to any study-related activity is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.\n* Has successfully completed the main study.\n\nExclusion Criterion:\n\n\\- Has been withdrawn from the main study.'}, 'identificationModule': {'nctId': 'NCT00268892', 'briefTitle': 'Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Different Three-Month Degarelix Dosing Regimens in Patients With Prostate Cancer', 'orgStudyIdInfo': {'id': 'FE200486 CS15A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Degarelix 240/240@40(1-3-6-9)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).', 'interventionNames': ['Drug: Degarelix']}, {'type': 'EXPERIMENTAL', 'label': 'Degarelix 240/240@60(1-3-6-9)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).', 'interventionNames': ['Drug: Degarelix']}, {'type': 'EXPERIMENTAL', 'label': 'Degarelix 240/240@60(1-4-7-10)', 'description': 'Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).', 'interventionNames': ['Drug: Degarelix']}], 'interventions': [{'name': 'Degarelix', 'type': 'DRUG', 'otherNames': ['FE200486'], 'description': 'Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).\n\nDrug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.', 'armGroupLabels': ['Degarelix 240/240@40(1-3-6-9)']}, {'name': 'Degarelix', 'type': 'DRUG', 'otherNames': ['FE200486'], 'description': 'Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).\n\nDrug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.', 'armGroupLabels': ['Degarelix 240/240@60(1-3-6-9)']}, {'name': 'Degarelix', 'type': 'DRUG', 'otherNames': ['FE200486'], 'description': 'Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).\n\nDrug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.', 'armGroupLabels': ['Degarelix 240/240@60(1-4-7-10)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Gasthuisberg Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Hospital, Maria Hospital, Building 11', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Joensuu', 'country': 'Finland', 'facility': 'Central Hospital, North Karelian', 'geoPoint': {'lat': 62.60118, 'lon': 29.76316}}, {'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Nice', 'country': 'France', 'facility': "Fédération d'Urologie et Néphrologie, BP69 Hôpital Pasteur", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Aachen', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Dres Effert und Benedic', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Novi Sad', 'country': 'Montenegro', 'facility': 'Clinical Center Novi Sad, Clinic of Urology'}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center, Urology', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'St. Elisabeth Hospital', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'city': 'Arad', 'country': 'Romania', 'facility': '"Centrul Medical Privat" Prof. Dr. Ioiart Ioan"', 'geoPoint': {'lat': 46.18333, 'lon': 21.31667}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'University CF Hospital No. 2', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Andros 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': 'Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Pavlov State Medical University, Urology Department', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Center of Serbia, Institute of Urology and Nephrology', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Northwood', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Mount Vernon Cancer Centre, Marie Cuire Research Wing', 'geoPoint': {'lat': 51.61162, 'lon': -0.42454}}, {'city': 'Hull', 'state': 'North Humberside', 'country': 'United Kingdom', 'facility': 'Castle Hill Hospital', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'city': 'Falkirk', 'country': 'United Kingdom', 'facility': 'Ward 13, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary, Majors Loans', 'geoPoint': {'lat': 56.0021, 'lon': -3.78535}}, {'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Level 7, Urology Research Unit, Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], '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'}}}}