Viewing Study NCT01234350

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Ignite Creation Date: 2025-12-24 @ 5:09 PM
Ignite Modification Date: 2025-12-27 @ 2:43 AM
Study NCT ID: NCT01234350
Status: COMPLETED
Last Update Posted: 2019-06-25
First Post: 2010-11-03
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DK0-Disclosure@ferring.com', 'title': 'Clinical Development Support', 'organization': 'Ferring Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)', 'description': 'An AE was defined as any untoward medical occurrence in a subject participating in a clinical investigation who received a pharmaceutical product.\n\nThe safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).', 'eventGroups': [{'id': 'EG000', 'title': 'FIRMAGON', 'description': 'FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label', 'otherNumAtRisk': 1000, 'deathsNumAtRisk': 1000, 'otherNumAffected': 294, 'seriousNumAtRisk': 1000, 'deathsNumAffected': 141, 'seriousNumAffected': 236}, {'id': 'EG001', 'title': 'GnRH Agonist', 'description': 'Any GnRH agonist prescribed in accordance with the approved labels', 'otherNumAtRisk': 493, 'deathsNumAtRisk': 493, 'otherNumAffected': 110, 'seriousNumAtRisk': 493, 'deathsNumAffected': 72, 'seriousNumAffected': 144}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 226, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Prostatic specific antigen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 90, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 29, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 172, 'numAffected': 166}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 92, 'numAffected': 88}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Immune thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Left ventricular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Coronary artery insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Subventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Incarcerated umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rectal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Small intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vertebral lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 41, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 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'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 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'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bladder cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bladder transitional cell carcinoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 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'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Prostatic obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rectoprostatic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Testicular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dyapnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lung consolidation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Thoracic haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Stevens-johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Eye prosthesis insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ileostomy closure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Medical induction of coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nephrostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Spinal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dry gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1000, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 493, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'OG000'}, {'value': '493', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FIRMAGON', 'description': 'FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label'}, {'id': 'OG001', 'title': 'GnRH Agonist', 'description': 'Any GnRH agonist prescribed in accordance with the approved labels'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'IRR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.829', 'ciLowerLimit': '0.536', 'ciUpperLimit': '1.283', 'pValueComment': 'Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.', 'estimateComment': 'IRR for treatment with the lower 95% confidence limit \\>1 suggest increased risk of AESI; upper confidence limit \\<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.', 'groupDescription': 'The IRs were estimated using a Poisson-mixture regression model.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The IRs for each treatment arm with 95% confidence interval (CI), and incidence rate ratio (IRRs) with 95% CI and p-values were based on Wald test.'}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)', 'description': 'The incidence rate (IR) expressed as number of events per 100 patient-years of exposure (PYE).', 'unitOfMeasure': 'Events per 100 PYE', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).'}, {'type': 'PRIMARY', 'title': 'Incidence Rate of AESI: Decreased Bone Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'OG000'}, {'value': '493', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FIRMAGON', 'description': 'FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label'}, {'id': 'OG001', 'title': 'GnRH Agonist', 'description': 'Any GnRH prescribed in accordance with the approved labels'}], 'classes': [{'title': 'Osteoporosis or Osteopenia', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Bone fracture', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6710', 'groupIds': ['OG000', 'OG001'], 'paramType': 'IRR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.874', 'ciLowerLimit': '0.470', 'ciUpperLimit': '1.626', 'pValueComment': 'Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.', 'estimateComment': 'IRR for treatment with the lower 95% confidence limit \\>1 suggest increased risk of AESI; upper confidence limit \\<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.', 'groupDescription': 'For osteoporosis and osteopenia events. The IRs were estimated using Poisson-mixture regression model.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.'}, {'pValue': '0.4544', 'groupIds': ['OG000', 'OG001'], 'paramType': 'IRR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.857', 'ciLowerLimit': '0.367', 'ciUpperLimit': '9.403', 'pValueComment': 'Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.', 'estimateComment': 'IRR for treatment with the lower 95% confidence limit \\>1 suggest increased risk of AESI; upper confidence limit \\<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.', 'groupDescription': 'For bone fracture events. The IRs were estimated using Poisson-mixture regression model.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.'}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)', 'description': 'IR of osteoporosis or osteopenia and bone fracture events are presented. The IR is expressed as number of events per 100 PYE.', 'unitOfMeasure': 'Events per 100 PYE', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).'}, {'type': 'PRIMARY', 'title': 'Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'OG000'}, {'value': '493', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FIRMAGON', 'description': 'FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label'}, {'id': 'OG001', 'title': 'GnRH Agonist', 'description': 'Any GnRH prescribed in accordance with the approved labels'}], 'classes': [{'title': 'Glucose intolerance', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'T2DM', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2529', 'groupIds': ['OG000', 'OG001'], 'paramType': 'IRR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.193', 'ciLowerLimit': '0.882', 'ciUpperLimit': '1.613', 'pValueComment': 'Poisson mixture regression was used to model the influence of age, stage of disease, and history of diabetes mellitus along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.', 'estimateComment': 'IRR for treatment with the lower 95% confidence limit \\>1 suggest increased risk of AESI; upper confidence limit \\<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.', 'groupDescription': 'For glucose intolerance. The IRs were estimated using Poisson-mixture regression model.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.'}, {'pValue': '0.0208', 'groupIds': ['OG000', 'OG001'], 'paramType': 'IRR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.623', 'ciLowerLimit': '1.158', 'ciUpperLimit': '5.944', 'pValueComment': 'Poisson-mixture regression is used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual trial exposures measured in 100 PYE.', 'estimateComment': 'IRR for treatment with the lower 95% confidence limit \\>1 suggest increased risk of AESI; upper confidence limit \\<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.', 'groupDescription': 'For T2DM. The IRs were estimated using Poisson-mixture regression model.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.'}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)', 'description': 'IR of new onset or exacerbation of glucose intolerance or T2DM were presented. The IR expressed as number of events per 100 PYE.\n\nGlucose intolerance events were defined as events of levels of fasting glucose of 6.1 to 6.9 mmol/L', 'unitOfMeasure': 'Events per 100 PYE', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).'}, {'type': 'PRIMARY', 'title': 'Change in Hepatic Enzymes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'OG000'}, {'value': '493', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FIRMAGON', 'description': 'FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label'}, {'id': 'OG001', 'title': 'GnRH Agonist', 'description': 'Any GnRH Agonist prescribed in accordance with the approved labels'}], 'classes': [{'title': 'ALT (Visit 2, Month 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-70', 'upperLimit': '63'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-19', 'upperLimit': '82'}]}]}, {'title': 'ALT (Visit 3, Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-65', 'upperLimit': '174'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-41', 'upperLimit': '125'}]}]}, {'title': 'ALT (Visit 4, Month 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-66', 'upperLimit': '55'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-22', 'upperLimit': '54'}]}]}, {'title': 'ALT (Visit 5, Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-63', 'upperLimit': '57'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-38', 'upperLimit': '49'}]}]}, {'title': 'ALT (Visit 6, Month 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-69', 'upperLimit': '30'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-44', 'upperLimit': '37'}]}]}, {'title': 'ALT (Visit 7, Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-68', 'upperLimit': '41'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-26', 'upperLimit': '77'}]}]}, {'title': 'ALT (Visit 8, Month 21)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-70', 'upperLimit': '204'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-25', 'upperLimit': '49'}]}]}, {'title': 'ALT (Visit 9, Month 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-65', 'upperLimit': '332'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-24', 'upperLimit': '20'}]}]}, {'title': 'ALT (Visit 10, Month 30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-80', 'upperLimit': '28'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-23', 'upperLimit': '26'}]}]}, {'title': 'ALT (Visit 11, Month 36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-50', 'upperLimit': '317'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-16', 'upperLimit': '90'}]}]}, {'title': 'ALT (Visit 12, Month 42)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-35', 'upperLimit': '31'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-44', 'upperLimit': '33'}]}]}, {'title': 'ALT (Visit 13, Month 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-36', 'upperLimit': '97'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-45', 'upperLimit': '28'}]}]}, {'title': 'ALT (Visit 14, Month 54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-53', 'upperLimit': '32'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-32', 'upperLimit': '13'}]}]}, {'title': 'ALT (Visit 15, end of trial [EOT], Month 60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-30', 'upperLimit': '33'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-16', 'upperLimit': '16'}]}]}, {'title': 'ALP (Visit 2, Month 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-661', 'upperLimit': '738'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-632', 'upperLimit': '240'}]}]}, {'title': 'ALP (Visit 3, Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-990', 'upperLimit': '979'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-649', 'upperLimit': '135'}]}]}, {'title': 'ALP (Visit 4, Month 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-1009', 'upperLimit': '1024'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-658', 'upperLimit': '225'}]}]}, {'title': 'ALP (Visit 5, Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-1029', 'upperLimit': '614'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-661', 'upperLimit': '184'}]}]}, {'title': 'ALP (Visit 6, Month 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-1027', 'upperLimit': '957'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-225', 'upperLimit': '370'}]}]}, {'title': 'ALP (Visit 7, Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-1031', 'upperLimit': '475'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-217', 'upperLimit': '889'}]}]}, {'title': 'ALP (Visit 8, Month 21)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-539', 'upperLimit': '777'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-197', 'upperLimit': '364'}]}]}, {'title': 'ALP (Visit 9, Month 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-756', 'upperLimit': '307'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-228', 'upperLimit': '446'}]}]}, {'title': 'ALP (Visit 10, Month 30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-540', 'upperLimit': '300'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-211', 'upperLimit': '169'}]}]}, {'title': 'ALP (Visit 11, Month 36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-764', 'upperLimit': '748'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-185', 'upperLimit': '386'}]}]}, {'title': 'ALP (Visit 12, Month 42)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-773', 'upperLimit': '1238'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-182', 'upperLimit': '235'}]}]}, {'title': 'ALP (Visit 13, Month 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-785', 'upperLimit': '657'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-204', 'upperLimit': '114'}]}]}, {'title': 'ALP (Visit 14, Month 54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-779', 'upperLimit': '79'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '-197', 'upperLimit': '104'}]}]}, {'title': 'ALP (Visit 15 [EOT], Month 60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'groupId': 'OG000', 'lowerLimit': '-756', 'upperLimit': '164'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-157', 'upperLimit': '89'}]}]}, {'title': 'AST (Visit 2, Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-72', 'upperLimit': '64'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-82', 'upperLimit': '49'}]}]}, {'title': 'AST (Visit 3, Month 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-73', 'upperLimit': '79'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-74', 'upperLimit': '37'}]}]}, {'title': 'AST (Visit 4, Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-68', 'upperLimit': '69'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-41', 'upperLimit': '60'}]}]}, {'title': 'AST (Visit 5, Month 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-72', 'upperLimit': '44'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-77', 'upperLimit': '108'}]}]}, {'title': 'AST (Visit 6, Month 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-73', 'upperLimit': '194'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-78', 'upperLimit': '54'}]}]}, {'title': 'AST (Visit 7, Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-72', 'upperLimit': '108'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-37', 'upperLimit': '60'}]}]}, {'title': 'AST (Visit 8, Month 21)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-73', 'upperLimit': '25'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-45', 'upperLimit': '73'}]}]}, {'title': 'AST (Visit 9, Month 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-75', 'upperLimit': '68'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-43', 'upperLimit': '32'}]}]}, {'title': 'AST (Visit 10, Month 30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-73', 'upperLimit': '28'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-46', 'upperLimit': '665'}]}]}, {'title': 'AST (Visit 11, Month 36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-72', 'upperLimit': '57'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-43', 'upperLimit': '43'}]}]}, {'title': 'AST (Visit 12, Month 40)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-70', 'upperLimit': '21'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-53', 'upperLimit': '30'}]}]}, {'title': 'AST (Visit 13, Month 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-70', 'upperLimit': '167'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-52', 'upperLimit': '18'}]}]}, {'title': 'AST (Visit 14, Month 54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-68', 'upperLimit': '34'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-48', 'upperLimit': '29'}]}]}, {'title': 'AST (Visit 15 [EOT], Month 60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-35', 'upperLimit': '22'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-42', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)', 'description': 'Change from baseline in hepatic enzyme levels (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], and alkaline phosphatase \\[ALP\\]) are presented.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).'}, {'type': 'PRIMARY', 'title': 'Change in Hepatic Enzymes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'OG000'}, {'value': '493', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FIRMAGON', 'description': 'FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label'}, {'id': 'OG001', 'title': 'GnRH Agonist', 'description': 'Any GnRH prescribed in accordance with the approved labels'}], 'classes': [{'title': 'Visit 2, Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-169', 'upperLimit': '97'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-108', 'upperLimit': '15'}]}]}, {'title': 'Visit 3, Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-234', 'upperLimit': '216'}, {'value': '-2.0', 'groupId': 'OG001', 'lowerLimit': '-16', 'upperLimit': '136'}]}]}, {'title': 'Visit 4, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-233', 'upperLimit': '38'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-18', 'upperLimit': '93'}]}]}, {'title': 'Visit 5, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-98', 'upperLimit': '113'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-285', 'upperLimit': '13'}]}]}, {'title': 'Visit 6, Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-22', 'upperLimit': '166'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-23', 'upperLimit': '245'}]}]}, {'title': 'Visit 7, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000', 'lowerLimit': '-99', 'upperLimit': '111'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-28', 'upperLimit': '65'}]}]}, {'title': 'Visit 8, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 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The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).'}, {'type': 'SECONDARY', 'title': 'All-cause of Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'OG000'}, {'value': '493', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FIRMAGON', 'description': 'FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label'}, {'id': 'OG001', 'title': 'GnRH Agonist', 'description': 'Any GnRH agonist prescribed in accordance with the approved labels'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0821', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.747', 'ciLowerLimit': '0.537', 'ciUpperLimit': '1.038', 'pValueComment': 'A logistic regression was used to model the influence of age, stage of disease and relevant medical history along with the treatment group on the time to event for all-cause mortality.', 'groupDescription': 'The analyses of all-cause mortality was based on logistic regressions.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Logistic regression was used to model the influence of age, stage of disease and relevant medical history along with the treatment group.'}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)', 'description': 'A summary of IRs of all-cause mortality is presented.', 'unitOfMeasure': 'Events per 100 PYE', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FIRMAGON', 'description': 'FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label'}, {'id': 'FG001', 'title': 'GnRH Agonist', 'description': 'Any GnRH agonist prescribed in accordance with the approved labels'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1000'}, {'groupId': 'FG001', 'numSubjects': '493'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '313'}, {'groupId': 'FG001', 'numSubjects': '226'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '687'}, {'groupId': 'FG001', 'numSubjects': '267'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '277'}, {'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'Covers a diverse set of reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '234'}, {'groupId': 'FG001', 'numSubjects': '92'}]}]}], 'recruitmentDetails': 'A total of 136 sites in 15 European countries (Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Portugal, Slovakia, Switzerland, United Kingdom) recruited subjects to this observational study between January 2011 to April 2013, and the last subject completed the last visit in March 2018.', 'preAssignmentDetails': 'A total of 1,515 subjects were screened, of which 1,493 subjects were found to be eligible and exposed to treatment; 1,000 subjects in the FIRMAGON group and 493 subjects in the gonadotrophin releasing hormone (GnRH) agonist group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'BG000'}, {'value': '493', 'groupId': 'BG001'}, {'value': '1493', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FIRMAGON', 'description': 'FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label'}, {'id': 'BG001', 'title': 'GnRH Agonist', 'description': 'Any GnRH agonist prescribed in accordance with the approved labels'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '999', 'groupId': 'BG000'}, {'value': '493', 'groupId': 'BG001'}, {'value': '1492', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71.9', 'spread': '8.33', 'groupId': 'BG000'}, {'value': '73.2', 'spread': '8.27', 'groupId': 'BG001'}, {'value': '72.4', 'spread': '8.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed differs from the overall population as age was not recorded for some of the subjects.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'BG000'}, {'value': '493', 'groupId': 'BG001'}, {'value': '1493', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1000', 'groupId': 'BG000'}, {'value': '493', 'groupId': 'BG001'}, {'value': '1493', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '780', 'groupId': 'BG000'}, {'value': '385', 'groupId': 'BG001'}, {'value': '1165', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '697', 'groupId': 'BG000'}, {'value': '353', 'groupId': 'BG001'}, {'value': '1050', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Ethnicity was not recorded for some subjects.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '780', 'groupId': 'BG000'}, {'value': '385', 'groupId': 'BG001'}, {'value': '1165', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '745', 'groupId': 'BG000'}, {'value': '360', 'groupId': 'BG001'}, {'value': '1105', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed differs from the overall population as race was not recorded for some of the subjects.'}, {'title': 'BMI (kg/m^2)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '786', 'groupId': 'BG000'}, {'value': '406', 'groupId': 'BG001'}, {'value': '1192', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'spread': '3.91', 'groupId': 'BG000'}, {'value': '26.8', 'spread': '3.82', 'groupId': 'BG001'}, {'value': '26.9', 'spread': '3.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed differs from the overall population as baseline body mass index (BMI) was not calculated for some of the subjects.'}], 'populationDescription': 'The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in androgen deprivation therapy \\[ADT\\], or end-of-study visit, whatever came first).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2010-06-01', 'size': 1160431, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-21T06:18', 'hasProtocol': True}, {'date': '2014-08-08', 'size': 505529, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-02-21T06:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1493}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-14', 'studyFirstSubmitDate': '2010-11-03', 'resultsFirstSubmitDate': '2019-02-21', 'studyFirstSubmitQcDate': '2010-11-03', 'lastUpdatePostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-21', 'studyFirstPostDateStruct': {'date': '2010-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events', 'timeFrame': 'From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)', 'description': 'The incidence rate (IR) expressed as number of events per 100 patient-years of exposure (PYE).'}, {'measure': 'Incidence Rate of AESI: Decreased Bone Density', 'timeFrame': 'From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)', 'description': 'IR of osteoporosis or osteopenia and bone fracture events are presented. The IR is expressed as number of events per 100 PYE.'}, {'measure': 'Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM)', 'timeFrame': 'From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)', 'description': 'IR of new onset or exacerbation of glucose intolerance or T2DM were presented. The IR expressed as number of events per 100 PYE.\n\nGlucose intolerance events were defined as events of levels of fasting glucose of 6.1 to 6.9 mmol/L'}, {'measure': 'Change in Hepatic Enzymes', 'timeFrame': 'From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)', 'description': 'Change from baseline in hepatic enzyme levels (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], and alkaline phosphatase \\[ALP\\]) are presented.'}, {'measure': 'Change in Hepatic Enzymes', 'timeFrame': 'From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)', 'description': 'Change from baseline in hepatic enzyme level (bilirubin) is presented.'}, {'measure': 'Change in Serum Glucose', 'timeFrame': 'From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)', 'description': 'Change from baseline in serum glucose are presented.'}], 'secondaryOutcomes': [{'measure': 'Number and Classification of New Adverse Drug Reactions (ADRs)', 'timeFrame': 'From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)', 'description': 'An ADR was defined as an AE assessed by investigator as possibly/probably related to the investigational product. Any new potentially unrecognized ADRs were presented.'}, {'measure': 'Long Term Evaluation of Clinical Evolution of Prostate Cancer', 'timeFrame': 'From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)', 'description': 'Change in prostate specific antigen (PSA) is presented.'}, {'measure': 'Changes in Testosterone Levels', 'timeFrame': 'From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)', 'description': 'Change from baseline in testosterone levels are presented.'}, {'measure': 'All-cause of Mortality', 'timeFrame': 'From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)', 'description': 'A summary of IRs of all-cause mortality is presented.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a large observational study, set-up to observe how long-term treatment with FIRMAGON (hormone regulator) compare to other treatments in regards to cardiovascular events, changes in bone density, changes in blood sugar levels or liver enzyme levels in subjects with prostate cancer. Subjects will be treated according to their routine clinical care and not dictated by the study. As the study is observational in nature, the study will collect data relating to the events specified above. Subjects that agree to this study will be followed-up for 5 years. Subject data will be collected every 3 months for the first 2 years and every 6 months for the last 3 years.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with prostate cancer from primary care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with prostate cancer and indicated for androgen deprivation therapy (ADT)\n* Decision made to prescribe ADT prior to enrolment\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Participation in an interventional clinical study in which any treatment or follow-up is mandated\n* Treatment with a GnRH receptor antagonist other than FIRMAGON\n* Had previous or is currently under hormonal management of prostate cancer, except for subjects who have undergone therapy with curative intention where neoadjuvant/adjuvant therapy allowed for maximum 6 months. Treatment should be terminated at least 6 months prior to baseline.'}, 'identificationModule': {'nctId': 'NCT01234350', 'briefTitle': 'A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Prospective Observational Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON (Degarelix) or a GnRH Agonist', 'orgStudyIdInfo': {'id': 'FE200486 CS39'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FIRMAGON'}, {'label': 'GnRH Agonist'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalst', 'country': 'Belgium', 'facility': 'Onze-Lieve-Vrouwziekenhuis', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ Sint-Jan AV', 'geoPoint': {'lat': 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'facility': 'Centre Hospitalier Laennec', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Chu Gabriel Montpied', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Évry', 'country': 'France', 'facility': 'Ramsay Sante', 'geoPoint': {'lat': 48.6328, 'lon': 2.44049}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Groupement hospitalier Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Cabinet Médical 65 prado', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'CHU Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Hopital de la Conception', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Melun', 'country': 'France', 'facility': 'Polyclinique Saint-Jean', 'geoPoint': {'lat': 48.5457, 'lon': 2.65356}}, {'city': 'Montauban', 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