Viewing Study NCT01958918

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Ignite Creation Date: 2025-12-25 @ 5:04 AM
Ignite Modification Date: 2026-03-09 @ 8:50 AM
Study NCT ID: NCT01958918
Status: COMPLETED
Last Update Posted: 2019-03-21
First Post: 2013-10-07
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Greece']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'C533178', 'term': 'aflibercept'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '+41613241111', 'title': 'Study Director', 'organization': 'Novartis Pharma AG'}, 'certainAgreement': {'otherDetails': "The terms and condition of Novartis'agreements with its investigator may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'AE additional description', 'eventGroups': [{'id': 'EG000', 'title': 'Ranibizumab 0.5 mg', 'description': 'Ranibizumab 0.5 mg', 'otherNumAtRisk': 356, 'deathsNumAtRisk': 356, 'otherNumAffected': 156, 'seriousNumAtRisk': 356, 'deathsNumAffected': 1, 'seriousNumAffected': 67}, {'id': 'EG001', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg', 'otherNumAtRisk': 356, 'deathsNumAtRisk': 356, 'otherNumAffected': 156, 'seriousNumAtRisk': 356, 'deathsNumAffected': 3, 'seriousNumAffected': 74}], 'otherEvents': [{'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 28}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 23}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 25}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 62}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 21}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Systolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Amaurosis fugax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Angle closure glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Detachment of macular retinal pigment epithelium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Ectropion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Eye haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Ocular hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Retinal pigment epithelial tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Ulcerative keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Vitreous adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Intestinal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Portal hypertensive gastropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Varices oesophageal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Medical device site joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Akinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Brain stem stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cervical myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Formication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Glossopharyngeal neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hyperkinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Peripheral sensorimotor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Vascular dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Emotional distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Urethral dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Atrophic vulvovaginitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 356, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean of the Absolute Values of CSRT Difference Month 3 to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': '0.5 mg intravitreal injections of ranibizumab monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity.'}, {'id': 'OG001', 'title': 'Aflibercept', 'description': '2 mg intravitreal injections of aflibercept monthly for the first 3 months, followed by 2 mg intravitreal injections once every 2 months (current EU SmPC label)'}], 'classes': [{'categories': [{'measurements': [{'value': '25.16', 'spread': '2.584', 'groupId': 'OG000'}, {'value': '29.28', 'spread': '2.620', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1850', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Month 3, Month 4, Month 5, Month 6', 'description': 'The thickness of the retina was measured by Spectral Domain Optical Coherence Topography (SD-OCT). The mean of the absolute values of the CSRT difference between Month 3 and 4, Month 4 and 5, and Month 5 and 6 was calculated (ie, CSRT fluctuation). A lower average CSRT fluctuation demonstrates greater retinal stability. One eye (study eye) contributed to the analysis.', 'unitOfMeasure': 'micrometers', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Number analyzed is the number of patients with a measurement'}, {'type': 'SECONDARY', 'title': 'Total Best Corrected Visual Acuity (BCVA) Score Measured in ETDRS Letters at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': '0.5 mg intravitreal injections of ranibizumab monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity.'}, {'id': 'OG001', 'title': 'Aflibercept', 'description': '2 mg intravitreal injections of aflibercept monthly for the first 3 months, followed by 2 mg intravitreal injections once every 2 months (current EU SmPC label)'}], 'classes': [{'categories': [{'measurements': [{'value': '66.4', 'spread': '18.10', 'groupId': 'OG000'}, {'value': '68', 'spread': '17.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'Visual acuity was assessed in a sitting position with refraction using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. A higher score indicates better visual acuity. ETDRS scale ranges from 0-100 letters. A score of 65 to 70 letters represents a low to moderate visual acuity', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with measurement at visit Month 12. No statistical analysis was performed.'}, {'type': 'SECONDARY', 'title': 'IREST at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': '0.5 mg intravitreal injections of ranibizumab monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity.'}, {'id': 'OG001', 'title': 'Aflibercept', 'description': '2 mg intravitreal injections of aflibercept monthly for the first 3 months, followed by 2 mg intravitreal injections once every 2 months (current EU SmPC label)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '21.19', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '21.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'Number of incorrectly read words (IREST) was assessed using International Reading Speed Texts (IResT) and measured in words per minute.', 'unitOfMeasure': 'incorrect words per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with measurement at Month 12. No statistical analysis was performed.'}, {'type': 'SECONDARY', 'title': 'National Eye Institute Visual Functioning Questionnaire Composite Score (VFQ-25) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': '0.5 mg intravitreal injections of ranibizumab monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity.'}, {'id': 'OG001', 'title': 'Aflibercept', 'description': '2 mg intravitreal injections of aflibercept monthly for the first 3 months, followed by 2 mg intravitreal injections once every 2 months (current EU SmPC label)'}], 'classes': [{'categories': [{'measurements': [{'value': '80.0', 'spread': '14.43', 'groupId': 'OG000'}, {'value': '79.1', 'spread': '14.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'Vision-related quality of life was assessed by the patient using the National Eye Institute Visual Function Questionnaire. The scores of 12 subscales (general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision) were added together for a total (composite) score, which ranged from 0 to 100. A higher score indicates poorer function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with measurement at Month 12. No statistical analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Correlations Between CSRT Fluctuation (Month 3 to 6) and Functional Outcomes at Month 12 (Full Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': '0.5 mg intravitreal injections of ranibizumab monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity.'}, {'id': 'OG001', 'title': 'Aflibercept', 'description': '2 mg intravitreal injections of aflibercept monthly for the first 3 months, followed by 2 mg intravitreal injections once every 2 months (current EU SmPC label)'}], 'classes': [{'title': 'Total BCVA Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2194', 'groupId': 'OG000'}, {'value': '0.0155', 'groupId': 'OG001'}]}]}, {'title': 'IREST reading speed (words/minute)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0889', 'groupId': 'OG000'}, {'value': '0.0450', 'groupId': 'OG001'}]}]}, {'title': 'VFQ-25 composite score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1064', 'groupId': 'OG000'}, {'value': '0.0847', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3 to Month 6, Month 12', 'description': "Correlation coefficient calculated based on Pearson's correlation between each corresponding parameter and CSRT stability.", 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set with measure. No statistical analysis was performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ranibizumab', 'description': '0.5 mg intravitreal injections of ranibizumab monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity.'}, {'id': 'FG001', 'title': 'Aflibercept', 'description': '2 mg intravitreal injections of aflibercept monthly for the first 3 months, followed by 2 mg intravitreal injections once every 2 months (current EU SmPC label)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'patients randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '356'}, {'groupId': 'FG001', 'numSubjects': '356'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '353'}, {'groupId': 'FG001', 'numSubjects': '354'}]}, {'type': 'COMPLETED', 'comment': 'completed overall', 'achievements': [{'groupId': 'FG000', 'numSubjects': '313'}, {'groupId': 'FG001', 'numSubjects': '314'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Patients were recruited from 6 sites in Austria, 2 sites in Belgium, 2 sites in Denmark and 5 sites from France.', 'preAssignmentDetails': 'This reporting group included all patients randomized to one of the treatment arms (Randomized Set)\n\nThe Full Analysis Set (FAS) consisted of all patients who received at least one application of study treatment and had at least one post-baseline assessment for SD-OCT.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'BG000'}, {'value': '354', 'groupId': 'BG001'}, {'value': '707', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ranibizumab', 'description': '0.5 mg intravitreal injections of ranibizumab monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity.'}, {'id': 'BG001', 'title': 'Aflibercept', 'description': '2 mg intravitreal injections of aflibercept monthly for the first 3 months, followed by 2 mg intravitreal injections once every 2 months (current EU SmPC label)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '77.3', 'spread': '7.53', 'groupId': 'BG000'}, {'value': '78.0', 'spread': '7.21', 'groupId': 'BG001'}, {'value': '77.7', 'spread': '7.38', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '428', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '350', 'groupId': 'BG000'}, {'value': '352', 'groupId': 'BG001'}, {'value': '702', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants', 'populationDescription': 'FAS'}], 'populationDescription': 'FAS'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The reading center was masked for treatment assignment in order to ensure unbiased evaluation of the primary, secondary and exploratory objectives that were determined by SDOCT, autofluorescence imaging, and microperimetry and multifocal ERG (where available).\n\nWhen communicating with the reading center study centers had to be vigilant not to unblind the reading center to the treatment.\n\nSite staff performing the assessments of BCVA, contrast sensitivity (where possible), VFQ25 and IReST (reading speed) were also masked to the identity of the treatment.\n\nThe central laboratory used for analysis of all specimens collected for biomarker assessment were blinded to the identity of the treatment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 712}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-12', 'studyFirstSubmitDate': '2013-10-07', 'resultsFirstSubmitDate': '2018-05-17', 'studyFirstSubmitQcDate': '2013-10-07', 'lastUpdatePostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-12', 'studyFirstPostDateStruct': {'date': '2013-10-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean of the Absolute Values of CSRT Difference Month 3 to Month 6', 'timeFrame': 'Month 3, Month 4, Month 5, Month 6', 'description': 'The thickness of the retina was measured by Spectral Domain Optical Coherence Topography (SD-OCT). The mean of the absolute values of the CSRT difference between Month 3 and 4, Month 4 and 5, and Month 5 and 6 was calculated (ie, CSRT fluctuation). A lower average CSRT fluctuation demonstrates greater retinal stability. One eye (study eye) contributed to the analysis.'}], 'secondaryOutcomes': [{'measure': 'Total Best Corrected Visual Acuity (BCVA) Score Measured in ETDRS Letters at Month 12', 'timeFrame': 'Month 12', 'description': 'Visual acuity was assessed in a sitting position with refraction using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. A higher score indicates better visual acuity. ETDRS scale ranges from 0-100 letters. A score of 65 to 70 letters represents a low to moderate visual acuity'}, {'measure': 'IREST at Month 12', 'timeFrame': 'Month 12', 'description': 'Number of incorrectly read words (IREST) was assessed using International Reading Speed Texts (IResT) and measured in words per minute.'}, {'measure': 'National Eye Institute Visual Functioning Questionnaire Composite Score (VFQ-25) at Month 12', 'timeFrame': 'Month 12', 'description': 'Vision-related quality of life was assessed by the patient using the National Eye Institute Visual Function Questionnaire. The scores of 12 subscales (general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision) were added together for a total (composite) score, which ranged from 0 to 100. A higher score indicates poorer function.'}, {'measure': 'Correlations Between CSRT Fluctuation (Month 3 to 6) and Functional Outcomes at Month 12 (Full Analysis Set)', 'timeFrame': 'Month 3 to Month 6, Month 12', 'description': "Correlation coefficient calculated based on Pearson's correlation between each corresponding parameter and CSRT stability."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wet age-related macular degeneration (AMD)', 'ranibizumab', 'aflibercept', 'Best Corrected Visual Acuity (BCVA)', 'Spectral Domain Optical Coherence Tomography (SD-OCT)'], 'conditions': ['Neovascular Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability.', 'detailedDescription': 'Patients attended 14 scheduled study visits during 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Visual impairment predominantly due to neovascular AMD Active\n* Newly diagnosed, untreated, angiographically documented choroidal neovascularization (CNV) lesion\n\nKey Exclusion Criteria:\n\n* Stroke or myocardial infarction less than 3 Months prior to study entry\n* Active injection or inflammation of either eye at the time of study entry\n* Any type of systemic disease (or received treatment for it), including any medical condition (controlled or uncontrolled) that were to be expected to progress, recur, or change to an extent which could bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk'}, 'identificationModule': {'nctId': 'NCT01958918', 'acronym': 'SALT', 'briefTitle': 'Efficacy of Ranibizumab Prn 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