Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-02-28 @ 7:29 AM
Study NCT ID:
NCT01580020
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2012-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012170', 'term': 'Retinal Vein Occlusion'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D020256', 'term': 'Choroidal Neovascularization'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015354', 'term': 'Vision, Low'}, {'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialandresults.registries@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators 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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Ranibizumab (BRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally', 'otherNumAtRisk': 52, 'otherNumAffected': 35, 'seriousNumAtRisk': 52, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Dexamethasone (BRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required', 'otherNumAtRisk': 40, 'otherNumAffected': 28, 'seriousNumAtRisk': 40, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Ranibizumab (CRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally', 'otherNumAtRisk': 61, 'otherNumAffected': 45, 'seriousNumAtRisk': 61, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Dexamethasone (CRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required', 'otherNumAtRisk': 22, 'otherNumAffected': 16, 'seriousNumAtRisk': 22, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'FACTOR V LEIDEN MUTATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CATARACT (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CONJUNCTIVAL HAEMORRHAGE (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CONJUNCTIVAL HYPERAEMIA (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CONJUNCTIVAL IRRITATION (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CONJUNCTIVITIS ALLERGIC (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DRY EYE (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DRY EYE (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'EYE PAIN (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'FOREIGN BODY SENSATION IN EYES (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'GLAUCOMA (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'LACRIMATION INCREASED (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'MACULAR FIBROSIS (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'MACULAR OEDEMA (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'OCULAR DISCOMFORT (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'OCULAR HYPERAEMIA (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PHOTOPSIA (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RETINAL EXUDATES (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RETINAL ISCHAEMIA (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RETINAL OEDEMA (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VISION BLURRED (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VISUAL ACUITY REDUCED (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VISUAL IMPAIRMENT (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VITREOUS DETACHMENT (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VITREOUS DETACHMENT (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CHEST DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CONJUNCTIVITIS (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'GASTROINTESTINAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HERPES ZOSTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PERIODONTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'MUSCLE STRAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'POST PROCEDURAL SWELLING (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INTRAOCULAR PRESSURE DECREASED (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INTRAOCULAR PRESSURE INCREASED (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VITAMIN D DEFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "SJOGREN'S SYNDROME", 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'SCIATICA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'TRIGEMINAL NEURALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'GLAUCOMA (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'GLAUCOMA (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'IRIS NEOVASCULARISATION (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'MACULAR OEDEMA (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'OCULAR ISCHAEMIC SYNDROME (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RETINAL DETACHMENT (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VISUAL ACUITY REDUCED (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VITREOUS HAEMORRHAGE (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ROTATOR CUFF SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'SQUAMOUS CELL CARCINOMA OF SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'LUMBAR RADICULOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'SUBSTANCE ABUSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PSORIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events as a Measure of Safety and Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab (BRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone (BRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.'}, {'id': 'OG002', 'title': 'Ranibizumab (CRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG003', 'title': 'Dexamethasone (CRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required'}], 'classes': [{'title': 'Adverse event', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The number of participants who experienced Adverse events, serious AE and death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received.'}, {'type': 'SECONDARY', 'title': 'Raw Mean Best Corrected Visual Acuity (BCVA) by Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab (BRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone (BRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.'}, {'id': 'OG002', 'title': 'Ranibizumab (CRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG003', 'title': 'Dexamethasone (CRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '56.8', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '58.3', 'spread': '10.8', 'groupId': 'OG001'}, {'value': '53.8', 'spread': '15.7', 'groupId': 'OG002'}, {'value': '53.2', 'spread': '16.1', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '77.9', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '69.2', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '72.6', 'spread': '13.5', 'groupId': 'OG002'}, {'value': '64.1', 'spread': '24.0', 'groupId': 'OG003'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '79.0', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '70.6', 'spread': '13.9', 'groupId': 'OG001'}, {'value': '72.6', 'spread': '15.8', 'groupId': 'OG002'}, {'value': '66.6', 'spread': '22.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement', 'unitOfMeasure': 'Letters read correctly', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters at Month 12 Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab (BRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone (BRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.'}, {'id': 'OG002', 'title': 'Ranibizumab (CRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG003', 'title': 'Dexamethasone (CRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required'}], 'classes': [{'title': 'Gain≥15 letters', 'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '58.3', 'groupId': 'OG002'}, {'value': '45.5', 'groupId': 'OG003'}]}]}, {'title': 'Gain ≥10 letters', 'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000'}, {'value': '65.0', 'groupId': 'OG001'}, {'value': '75.0', 'groupId': 'OG002'}, {'value': '68.2', 'groupId': 'OG003'}]}]}, {'title': 'Gain ≥5 letters', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}, {'value': '86.7', 'groupId': 'OG002'}, {'value': '77.3', 'groupId': 'OG003'}]}]}, {'title': 'Loss of ≥15 letters', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '7.5', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '4.5', 'groupId': 'OG003'}]}]}, {'title': 'Loss of ≥10 letters', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '4.5', 'groupId': 'OG003'}]}]}, {'title': 'Loss of ≥5 letters', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}, {'value': '4.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 month', 'description': 'BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who were gaining/losing ≥15, 10 or 5 more letters of visual acuity at month 12 as compared with baseline', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned'}, {'type': 'SECONDARY', 'title': 'Change in Central Subfield Thickness (CSRT) From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab (BRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone (BRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.'}, {'id': 'OG002', 'title': 'Ranibizumab (CRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG003', 'title': 'Dexamethasone (CRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required'}], 'classes': [{'categories': [{'measurements': [{'value': '-288.1', 'spread': '180.6', 'groupId': 'OG000'}, {'value': '-211.5', 'spread': '199.3', 'groupId': 'OG001'}, {'value': '-374.6', 'spread': '239.8', 'groupId': 'OG002'}, {'value': '-360.3', 'spread': '260.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline , Month 12', 'description': 'High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.', 'unitOfMeasure': 'um', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.'}, {'type': 'SECONDARY', 'title': 'Change of Foveal Center Point Thickness (FCPT) From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab (BRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone (BRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.'}, {'id': 'OG002', 'title': 'Ranibizumab (CRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG003', 'title': 'Dexamethasone (CRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required'}], 'classes': [{'categories': [{'measurements': [{'value': '-341.8', 'spread': '226.2', 'groupId': 'OG000'}, {'value': '-252.6', 'spread': '197.9', 'groupId': 'OG001'}, {'value': '-439.4', 'spread': '279.8', 'groupId': 'OG002'}, {'value': '-432.3', 'spread': '245.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'FCPT (foveal center point thickness) was assessed by central reading center to ensure error- corrected measurements of retinal thickness and volumes,', 'unitOfMeasure': 'um', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Visual Function Questionnaire (VFQ-25)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab (BRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone (BRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.'}, {'id': 'OG002', 'title': 'Ranibizumab (CRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG003', 'title': 'Dexamethasone (CRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required'}], 'classes': [{'title': 'Overall Composite', 'categories': [{'measurements': [{'value': '8.1', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '11.3', 'groupId': 'OG001'}, {'value': '9.1', 'spread': '15.5', 'groupId': 'OG002'}, {'value': '10.0', 'spread': '15.9', 'groupId': 'OG003'}]}]}, {'title': 'General Health', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '18.6', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '18.9', 'groupId': 'OG002'}, {'value': '5.7', 'spread': '20.3', 'groupId': 'OG003'}]}]}, {'title': 'General Vision', 'categories': [{'measurements': [{'value': '15.0', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '16.3', 'groupId': 'OG001'}, {'value': '20.0', 'spread': '17.7', 'groupId': 'OG002'}, {'value': '13.6', 'spread': '23.4', 'groupId': 'OG003'}]}]}, {'title': 'Ocular Pain', 'categories': [{'measurements': [{'value': '5.3', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '13.8', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '20.8', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '15.0', 'groupId': 'OG003'}]}]}, {'title': 'Near Activities', 'categories': [{'measurements': [{'value': '13.3', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '20.6', 'groupId': 'OG001'}, {'value': '12.3', 'spread': '20.5', 'groupId': 'OG002'}, {'value': '12.3', 'spread': '23.2', 'groupId': 'OG003'}]}]}, {'title': 'Distance Activities', 'categories': [{'measurements': [{'value': '8.9', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '15.3', 'groupId': 'OG001'}, {'value': '7.8', 'spread': '18.3', 'groupId': 'OG002'}, {'value': '8.3', 'spread': '23.4', 'groupId': 'OG003'}]}]}, {'title': 'Social Functioning', 'categories': [{'measurements': [{'value': '3.4', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '12.0', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '16.7', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '21.1', 'groupId': 'OG003'}]}]}, {'title': 'Mental Health', 'categories': [{'measurements': [{'value': '10.2', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '20.4', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '21.7', 'groupId': 'OG002'}, {'value': '15.1', 'spread': '18.3', 'groupId': 'OG003'}]}]}, {'title': 'Role Difficulties', 'categories': [{'measurements': [{'value': '4.8', 'spread': '26.8', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '20.5', 'groupId': 'OG001'}, {'value': '14.6', 'spread': '29.9', 'groupId': 'OG002'}, {'value': '24.4', 'spread': '27.8', 'groupId': 'OG003'}]}]}, {'title': 'Dependency', 'categories': [{'measurements': [{'value': '3.2', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '16.6', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '16.7', 'groupId': 'OG002'}, {'value': '4.4', 'spread': '12.8', 'groupId': 'OG003'}]}]}, {'title': 'Driving (BRVO n=44,31) (CRVO n=42,16)', 'categories': [{'measurements': [{'value': '11.7', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '21.3', 'groupId': 'OG001'}, {'value': '14.2', 'spread': '24.6', 'groupId': 'OG002'}, {'value': '17.7', 'spread': '25.1', 'groupId': 'OG003'}]}]}, {'title': 'Color Vision(BRVO n=52,39)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '17.5', 'groupId': 'OG002'}, {'value': '-1.1', 'spread': '14.4', 'groupId': 'OG003'}]}]}, {'title': 'Peripheral Vision(BRVO n=51,40)', 'categories': [{'measurements': [{'value': '10.3', 'spread': '24.1', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '23.3', 'groupId': 'OG001'}, {'value': '11.7', 'spread': '25.0', 'groupId': 'OG002'}, {'value': '14.8', 'spread': '22.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 months', 'description': 'The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.'}, {'type': 'SECONDARY', 'title': 'Change in SF-36 Summary Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab (BRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone (BRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.'}, {'id': 'OG002', 'title': 'Ranibizumab (CRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG003', 'title': 'Dexamethasone (CRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required'}], 'classes': [{'title': 'Physical Component(BRVO n=50,39) (CRVO n=58,20)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '7.0', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '8.2', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '7.2', 'groupId': 'OG003'}]}]}, {'title': 'Mental Component (BRVO n=50,39) (CRVO n=58,20)', 'categories': [{'measurements': [{'value': '3.3', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '13.2', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '9.3', 'groupId': 'OG002'}, {'value': '2.4', 'spread': '12.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, month 12', 'description': 'The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. A positive change from Baseline score indicates improvement in quality of life.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.'}, {'type': 'SECONDARY', 'title': 'Change in Euro Quality of Life Questionnaire (EQ-5D) VAS Summary Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab (BRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone (BRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.'}, {'id': 'OG002', 'title': 'Ranibizumab (CRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG003', 'title': 'Dexamethasone (CRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '16.9', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '16.4', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '20.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, month 12', 'description': 'The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled "Best imaginable health state" (100) and "worst imaginable health state" (0).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.'}, {'type': 'SECONDARY', 'title': 'Time to the First Retreatment of Both Treatment Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab (BRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone (BRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.'}, {'id': 'OG002', 'title': 'Ranibizumab (CRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG003', 'title': 'Dexamethasone (CRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '56'}, {'value': 'NA', 'comment': 'Not calculable because \\<50% of patients received re-treatment', 'groupId': 'OG001', 'lowerLimit': '328', 'upperLimit': 'NA'}, {'value': '62', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '67'}, {'value': 'NA', 'comment': 'Not calculable because \\<50% of patients received re-treatment', 'groupId': 'OG003', 'lowerLimit': '309', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Time to the first retreatment', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ranibizumab (BRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'FG001', 'title': 'Dexamethasone (BRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.'}, {'id': 'FG002', 'title': 'Ranibizumab (CRVO)', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitrally'}, {'id': 'FG003', 'title': 'Dexamethasone (CRVO)', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '61'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '57'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Administrative Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 140 patients with (BRVO) completed the core study CRFB002EDE17, and 127 patients with (CRVO) completed the core study CRFB002EDE18. 92 patients with BRVO and 83 patients with CRVO were enrolled into the extension study. A total of 175 patients (113 in the ranibizumab group and 62 in the dexamethasone group) were enrolled', 'preAssignmentDetails': 'The Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. LOCF=last observation carried forward'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ranibizumab', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'BG001', 'title': 'Dexamethasone', 'description': 'A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '64.8', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-11', 'studyFirstSubmitDate': '2012-04-16', 'resultsFirstSubmitDate': '2015-09-28', 'studyFirstSubmitQcDate': '2012-04-17', 'lastUpdatePostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-11', 'studyFirstPostDateStruct': {'date': '2012-04-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '6 months', 'description': 'The number of participants who experienced Adverse events, serious AE and death'}], 'secondaryOutcomes': [{'measure': 'Raw Mean Best Corrected Visual Acuity (BCVA) by Treatment Group', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement'}, {'measure': 'Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters at Month 12 Compared to Baseline', 'timeFrame': '12 month', 'description': 'BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who were gaining/losing ≥15, 10 or 5 more letters of visual acuity at month 12 as compared with baseline'}, {'measure': 'Change in Central Subfield Thickness (CSRT) From Baseline to Month 12', 'timeFrame': 'Baseline , Month 12', 'description': 'High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.'}, {'measure': 'Change of Foveal Center Point Thickness (FCPT) From Baseline to Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'FCPT (foveal center point thickness) was assessed by central reading center to ensure error- corrected measurements of retinal thickness and volumes,'}, {'measure': 'Change in Mean Visual Function Questionnaire (VFQ-25)', 'timeFrame': 'Baseline, 12 months', 'description': 'The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.'}, {'measure': 'Change in SF-36 Summary Scores', 'timeFrame': 'Baseline, month 12', 'description': 'The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. A positive change from Baseline score indicates improvement in quality of life.'}, {'measure': 'Change in Euro Quality of Life Questionnaire (EQ-5D) VAS Summary Scores', 'timeFrame': 'Baseline, month 12', 'description': 'The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled "Best imaginable health state" (100) and "worst imaginable health state" (0).'}, {'measure': 'Time to the First Retreatment of Both Treatment Arms', 'timeFrame': '6 months', 'description': 'Time to the first retreatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Macular Degeneration', 'Macular Edema', 'Retinal Vein Occlusion', 'Choroidal Neovascularization', 'Signs and Symptoms', 'Retinal Degeneration', 'Retinal Diseases', 'Eye Diseases', 'Venous Thrombosis Sensation Disorders', 'Dexamethasone acetate', 'Dexamethasone', 'Dexamethasone 21-phosphate', 'BB 1101', 'Anti-Inflammatory Agents', 'Therapeutic Uses', 'Vision, Low', 'Signs', 'Vision Disorders'], 'conditions': ['Retinal Vein Occlusion']}, 'descriptionModule': {'briefSummary': 'The study is intended to characterize the clinical benefit regarding safety and efficacy of a long term treatment with Lucentis in comparison with Ozurdex over an additional 6 months and a 3-month follow-up period, following the initial 6-month treatment in the respective core studies CRFB002EDE17 (NCT01396057) and CRFB002EDE18 (NCT01396083).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have completed the core study assessments at month 6 of study CRFB002EDE17 or CRFB002EDE18, respectively\n\nExclusion Criteria:\n\n* Patients who experienced an uncontrollable rise in IOP during the core study CRFB002EDE17 respectively CRFB002EDE18, i.e. IOP could not be decreased to a stable level of \\< 25mmHg.\n* Use of other investigational drugs\n* Current use or likely need of systemic medications known to be toxic to the lens, retina or optic nerve\n* History of hypersensitivity to Ranibizumab or Ozurdex or any component of the ranibizumab respectively Ozurdey formulation\n* Any type of advanced, severe or unstable disease or its treatment, that could interfere with evaluations or put the patient at special risk\n* Women\n* who were pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\\>5 mIU/mL)\n* who were menstruating and capable of becoming pregnant\\* and not practicing a medically approved method of contraception (Pearl Index \\<1\\*\\*)\\*\\*\\* during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (serum) for all women and for girls entering menarche was required with sufficient lead time before randomization\n\n * definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \\>40 mIU/mL or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy\n\n * examples of particularly reliable methods with Pearl Index (PI) \\<1, according to guidelines of "Deutsche Gesellschaft für Gynäkologie und Geburtshilfe":\n\n * Combination pill with estrogen and gestagen (no mini-pill, PI=0.1-0.9)\n * Vaginal ring (NuvaRing®, PI=0.65 uncorr.; 0.4 corr.)\n * Contraceptive patch (EVRA®, PI= 0.72 uncorr.; 0.9 corr.)\n * Estrogen-free ovulation inhibitors (Cerazette®, PI=0.14)\n * Progestin-containing contraceptives (Implanon®, PI=0-0.08)\n * Injectable 3-month depot progestins (PI=0.3-1.4; 0.88 corr.)\n * Intra-uterine progestin device (Mirena®, PI=0.16)'}, 'identificationModule': {'nctId': 'NCT01580020', 'briefTitle': 'Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open-label, Multi-center, 6-month Extension Study Comparing the Long-term Efficacy and Safety of Lucentis (Ranibizumab) Intravitreal Injections Versus Ozurdex (Dexamethasone) Intravitreal Implant in Patients With Visual Impairment Due to Macular Edema Following Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO) Who Have Completed the Respective Core Study (CRFB002EDE17 or CRFB002EDE18)', 'orgStudyIdInfo': {'id': 'CRFB002EDE20'}, 'secondaryIdInfos': [{'id': '2011-005045-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ranibizumab (Arm A)', 'description': 'The PRN injection scheme applied in the core study will also be followed during this extension study:\n\nPatients should be monitored monthly (starting at V1E) for VA and treatment is to be resumed when monitoring indicates loss of VA due to disease activity. Monthly injections should then be administered until stable VA is reached again for 3 consecutive monthly assessments (implying a minimum of 2 injections during stable VA). The interval between 2 doses should not be shorter than 1 month', 'interventionNames': ['Biological: RFB002']}, {'type': 'SHAM_COMPARATOR', 'label': 'Dexamethasone (Arm B)', 'description': 'A PRN re-treatment scheme will be applied for the Ozurdex arm during this extension study, i.e. patients may receive an implant at V1E or later as needed: Patients should be monitored monthly and if there is a decline from stable VA stability due to macular edema patients will receive another intravitreal implant. (700 µg; long acting release (LAR)) given that in the opinion of the investigator the patient would benefit from the re-treatment. However, a minimum period of 5 months in between implantations is required.', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'RFB002', 'type': 'BIOLOGICAL', 'description': '0.5 mg/0.05 mL solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. Each vial contained ranibizumab in an aqueous solution (pH 5.5) with histidine, trehalose and polysorbate 20.', 'armGroupLabels': ['Ranibizumab (Arm A)']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Ozurdex (Dexamethasone): intravitreal implant as per commercial label (700 µg Dexamethasone; Dexamethasone was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only. Dexamethasone had to be stored according to label instructions and it had to be kept in a secure locked facility', 'armGroupLabels': ['Dexamethasone (Arm B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04103', 'city': 'Leipzig', 'state': 'Germany', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '93042', 'city': 'Regensburg', 'state': 'Germany', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '85155', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '49214', 'city': 'Bad Rothenfelde', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.11667, 'lon': 8.16667}}, {'zip': '10713', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '28209', 'city': 'Bremen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': '09113', 'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '50935', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '64297', 'city': 'Darmstadt', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '40212', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '60318', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '79106', 'city': 'Freiburg I. 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