Viewing Study NCT01940900

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Ignite Creation Date: 2025-12-26 @ 12:18 PM
Ignite Modification Date: 2026-03-02 @ 10:35 PM
Study NCT ID: NCT01940900
Status: TERMINATED
Last Update Posted: 2024-10-30
First Post: 2013-09-09
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy
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': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D020256', 'term': 'Choroidal Neovascularization'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000621266', 'term': 'E10030 aptamer'}, {'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], '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': 'denise.teuber@ophthotech.com', 'title': 'Denise Teuber', 'organization': 'Ophthotech Corp.'}, 'certainAgreement': {'otherDetails': "Institution agrees not to individually publish the results of the Study without Ophthotech's prior written consent. Institution may participate in a joint, multi-center publication of the Study results with other investigators and/or institutions only, upon the prior written consent of Ophthotech.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 months of exposure', 'description': 'The efficacy (ITT) population, defined as all subjects randomized and received at least one dose of study drug, is different than the safety population, where all subjects who have received at least one dose of E10030 are analyzed as on that group. There was one subject who was randomized to Sham+Ranibizumab but was mis-treated with one dose of E10030 and therefore was analyzed in the E10030+ranibizuma group for safety purposes. This is the same explanation for the SAE and Mortality tables.', 'eventGroups': [{'id': 'EG000', 'title': 'E10030 + Ranibizumab', 'description': 'E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection\n\nE10030\n\nranibizumab', 'otherNumAtRisk': 312, 'deathsNumAtRisk': 312, 'otherNumAffected': 161, 'seriousNumAtRisk': 312, 'deathsNumAffected': 4, 'seriousNumAffected': 56}, {'id': 'EG001', 'title': 'Sham + Ranibizumab', 'description': 'E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection\n\nranibizumab\n\nE10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle', 'otherNumAtRisk': 314, 'deathsNumAtRisk': 314, 'otherNumAffected': 136, 'seriousNumAtRisk': 314, 'deathsNumAffected': 4, 'seriousNumAffected': 49}], 'otherEvents': [{'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 166, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 136, 'numAffected': 50}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 93, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 97, 'numAffected': 40}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Conjuctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 48, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 53, 'numAffected': 24}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 51, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 35, 'numAffected': 21}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 28, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 34, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 35, 'numAffected': 15}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 64, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 47, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 23, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 25, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 101, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 42, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}], 'seriousEvents': [{'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Follicle centre, lymphoma, follicular grade I, II, III stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Lung carcinoma cell type unspecified stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Lung squamous cell carcinoma stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Breast cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Malignant melanoma stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Cataract traumatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Periprosthetic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Splenic rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Heart valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Macular hole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Optic ischaemic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Retinal pigment epithelial tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Abdominal wall haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Inguinal hernia strangulated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Rectal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Urinary bladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Aspergillus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Chlostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Device related sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Infectious colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Vestibular neuronitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Urinary tract infection enterococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDR 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Visual Acuity From Baseline to 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E10030 + Ranibizumab', 'description': 'E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection\n\nE10030\n\nranibizumab'}, {'id': 'OG001', 'title': 'Sham + Ranibizumab', 'description': 'E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection\n\nranibizumab\n\nE10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle'}], 'classes': [{'categories': [{'measurements': [{'value': '9.91', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '10.36', 'spread': '0.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline to the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean change in visual acuity (ETDRS letter) from Baseline to Month 12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'E10030 + Ranibizumab', 'description': 'E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection\n\nE10030\n\nranibizumab'}, {'id': 'FG001', 'title': 'Sham + Ranibizumab', 'description': 'E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection\n\nranibizumab\n\nE10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '311'}, {'groupId': 'FG001', 'numSubjects': '315'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '282'}, {'groupId': 'FG001', 'numSubjects': '284'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'subject non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '627 patients were randomized but 1 patient was not treated'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'E10030 + Ranibizumab', 'description': 'E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection\n\nE10030\n\nranibizumab'}, {'id': 'BG001', 'title': 'Sham + Ranibizumab', 'description': 'E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection\n\nranibizumab\n\nE10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'title': 'Adults 18-64 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Adults 65-84 years', 'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '445', 'groupId': 'BG002'}]}, {'title': 'Adults 85 years and over', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '178', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Colombia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 627}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-19', 'studyFirstSubmitDate': '2013-09-09', 'resultsFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2013-09-09', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-13', 'studyFirstPostDateStruct': {'date': '2013-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Visual Acuity From Baseline to 12 Months', 'timeFrame': '12 Months', 'description': 'The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline to the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Wet AMD', 'choroidal neovascularization', 'Fovista®', 'E10030', 'Lucentis®'], 'conditions': ['Age-Related Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '30957581', 'type': 'DERIVED', 'citation': 'Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).', 'detailedDescription': 'Subjects will be randomized in a 1:1 ratio to the following dose groups:\n\n* Fovista® 1.5 mg/eye + Lucentis® 0.5 mg/eye\n* Fovista® sham + Lucentis® 0.5 mg/eye\n\nSubjects will be treated for a total of 24 months with active Fovista® or sham in combination with Lucentis® with the primary endpoint at 12 months.\n\nPrimary Efficacy Endpoint:\n\nThe primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the month 12 visit.\n\nSafety Endpoints:\n\nSafety endpoints include adverse events, vital signs, ophthalmic variables \\[ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)\\], ECG, and laboratory variables.\n\nApproximately 622 subjects will be randomized into one of the two treatment cohorts (311 patients per dose group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects of either gender aged ≥ 50 years\n* Active subfoveal choroidal neovascularization (CNV) secondary to AMD\n* Presence of sub-retinal hyper-reflective material (SD-OCT)\n\nExclusion Criteria:\n\n* Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals\n* Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids)\n* Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication\n* Subjects with subfoveal scar or subfoveal atrophy are excluded\n* Diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT01940900', 'briefTitle': 'A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.', 'orgStudyIdInfo': {'id': 'OPH1003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E10030 + ranibizumab', 'description': 'E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection', 'interventionNames': ['Drug: E10030', 'Drug: ranibizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sham + ranibizumab', 'description': 'E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection', 'interventionNames': ['Drug: ranibizumab', 'Drug: E10030 sham intravitreal injection']}], 'interventions': [{'name': 'E10030', 'type': 'DRUG', 'otherNames': ['Fovista®'], 'armGroupLabels': ['E10030 + ranibizumab']}, {'name': 'ranibizumab', 'type': 'DRUG', 'otherNames': ['Lucentis®'], 'armGroupLabels': ['E10030 + ranibizumab', 'Sham + ranibizumab']}, {'name': 'E10030 sham intravitreal injection', 'type': 'DRUG', 'otherNames': ['Sham'], 'description': 'Pressure on the eye with a syringe with no needle', 'armGroupLabels': ['Sham + ranibizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85710', 'city': 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