Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT01922102
Status:
COMPLETED
Last Update Posted:
2019-06-24
First Post:
2013-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Ranibizumab 0.5 vs Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020256', 'term': 'Choroidal Neovascularization'}], 'ancestors': [{'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye 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': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'D000077362', 'term': 'Verteporfin'}], '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'}, {'id': 'D011166', 'term': 'Porphyrins'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@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 (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Treatment, approximately 4 years.', 'description': 'Analysis was done in the safety set: consisted of all patients who received at least one application of study treatment and had at least one post-Baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no AEs also constitutes a safety assessment.\n\nOne patient randomized to vPDT Group III received one ranibizumab injection prior to Month 3; this patient was analyzed under Group II in Safety Set"', 'eventGroups': [{'id': 'EG000', 'title': 'Group I', 'description': '0.5 mg ranibizumab driven by visual acuity stability criteria', 'otherNumAtRisk': 182, 'otherNumAffected': 102, 'seriousNumAtRisk': 182, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Group II', 'description': '0.5 mg ranibizumab driven by disease activity criteria', 'otherNumAtRisk': 185, 'otherNumAffected': 116, 'seriousNumAtRisk': 185, 'seriousNumAffected': 15}, {'id': 'EG002', 'title': 'Group III With 0.5mg Ranibizumab', 'description': 'Visudyne PDT with 0.5mg ranibizumab from month 3', 'otherNumAtRisk': 75, 'otherNumAffected': 50, 'seriousNumAtRisk': 75, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Group III Without 0.5mg Ranibizumab', 'description': 'Visudyne PDT without 0.5mg ranibizumab from month 3', 'otherNumAtRisk': 14, 'otherNumAffected': 8, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cataract (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Choroidal neovascularisation (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Choroidal neovascularisation (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Conjunctival deposit (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Conjunctival deposit (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Conjunctival haemorrhage (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Conjunctival hyperaemia (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Conjunctivitis allergic (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Conjunctivitis allergic (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diplopia (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dry eye (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dry eye (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Exophthalmos (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Exophthalmos (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Eye pain (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Eye pain (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Eye pruritus (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Eye swelling (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Eye swelling (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Foreign body sensation in eyes (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Macular fibrosis (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Macular hole (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Metamorphopsia (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Metamorphopsia (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ocular discomfort (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ocular discomfort (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ocular hypertension (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pathologic myopia (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Photopsia (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Posterior capsule opacification (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Retinal haemorrhage (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Retinal haemorrhage (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vision blurred (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Visual acuity reduced (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Visual acuity reduced (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Visual impairment (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vitreous floaters (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vitreous opacities (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 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0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diabetic vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hyperaemia (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Retinal detachment (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Retinal detachment (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rectal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Varices oesophageal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Endophthalmitis (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pharyngitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Physical examination abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Shock hypoglycaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Osteoporotic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastrointestinal stromal tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Oligoastrocytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bladder hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Henoch-Schonlein purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I', 'description': '0.5 mg ranibizumab driven by visual acuity stability criteria'}, {'id': 'OG001', 'title': 'Group II', 'description': '0.5 mg ranibizumab driven by disease activity criteria'}, {'id': 'OG002', 'title': 'Group III', 'description': 'verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.7', 'spread': '12.65', 'groupId': 'OG000'}, {'value': '54.2', 'spread': '13.01', 'groupId': 'OG001'}, {'value': '52.6', 'spread': '12.29', 'groupId': 'OG002'}]}]}, {'title': 'Average Month 1 to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '63.1', 'spread': '12.80', 'groupId': 'OG000'}, {'value': '63.9', 'spread': '13.28', 'groupId': 'OG001'}, {'value': '57.1', 'spread': '13.21', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.2', 'ciLowerLimit': '3.3', 'ciUpperLimit': '7.1', 'pValueComment': 'Superiority could be claimed if the corresponding one-sided p-value was ≤ 0.025/2 = 0.0125, or if both one-sided p-values were ≤ 0.025.', 'estimateComment': 'Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.', 'groupDescription': '2 one-sided hypotheses were tested under the Type I error rate of 0.025, using the Hochberg procedure: H01: μRanibizumab-I - μvPDT ≤ 0 vs. HA1: μRanibizumab-I - μvPDT \\> 0 and H02: μRanibizumab-II - μvPDT ≤ 0 vs. HA2: μRanibizumab-II - μvPDT \\> 0, where μRanibizumab-I, μRanibizumab-II and μvPDT were the means of the primary efficacy variable for ranibizumab treatment Group I, ranibizumab treatment Group II, and vPDT treatment Group III, respectively.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.6', 'ciLowerLimit': '3.5', 'ciUpperLimit': '7.6', 'pValueComment': 'Superiority could be claimed if the corresponding one-sided p-value was ≤ 0.025/2 = 0.0125, or if both one-sided p-values were ≤ 0.025.', 'estimateComment': 'Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.', 'groupDescription': 'The following 2 one-sided hypotheses were tested under the Type I error rate of 0.025, using the Hochberg procedure:\n\nH01: μRanibizumab-I - μvPDT ≤ 0 vs. HA1: μRanibizumab-I - μvPDT \\> 0 and H02: μRanibizumab-II - μvPDT ≤ 0 vs. HA2: μRanibizumab-II - μvPDT \\> 0, where μRanibizumab-I, μRanibizumab-II and μvPDT were the means of the primary efficacy variable for ranibizumab treatment Group I, ranibizumab treatment Group II, and vPDT treatment Group III, respectively.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Month 3', 'description': 'Best corrected visual acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) charts testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.', 'unitOfMeasure': 'ETDRS letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): consisted of all patients to whom study treatment were assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I', 'description': '0.5 mg ranibizumab driven by visual acuity stability criteria'}, {'id': 'OG001', 'title': 'Group II', 'description': '0.5 mg ranibizumab driven by disease activity criteria'}, {'id': 'OG002', 'title': 'Group III', 'description': 'verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.7', 'spread': '12.65', 'groupId': 'OG000'}, {'value': '54.2', 'spread': '13.01', 'groupId': 'OG001'}, {'value': '52.6', 'spread': '12.29', 'groupId': 'OG002'}]}]}, {'title': 'Average Month 1 to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '64.1', 'spread': '12.77', 'groupId': 'OG000'}, {'value': '64.9', 'spread': '13.14', 'groupId': 'OG001'}, {'value': '59.6', 'spread': '12.99', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '2.1', 'pValueComment': 'Non-inferiority could be claimed if the corresponding one-sided p-value was ≤ 0.025.', 'estimateComment': 'Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'one-sided hypotheses were tested under the Type I error rate of 0.025, if H01 and H02 were rejected: H03: μRanibizumab-II - μRanibizumab-I ≤ -5 vs. HA3: μRanibizumab-II - μRanibizumab-I \\> -5.\n\nOtherwise, H03 was not to be considered as rejected.'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Month 6', 'description': 'Best corrected visual acuity (BCVA) was tested using the early treatment diabetic retinopathy study (ETDRS) VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.\n\nBetween treatment comparison of 0.5 mg ranibizumab intravitreal injections driven by disease activity re-treatment criteria (Group II) versus 0.5 mg ranibizumab intravitreal injections driven by visual acuity stability criteria (Group I) based on the average BCVA change from Baseline to Month 1 through Month 6.', 'unitOfMeasure': 'ETDRS letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): Following the intent-to-treat principle, patients were analyzed according to the treatment group they were assigned to at randomization.\n\nFAS, modified last observation carried forward (LOCF), for comparison between ranibizumab treatment groups.): consisted of all patients to whom study treatment were assigned.'}, {'type': 'SECONDARY', 'title': 'The Average Change in BCVA Score From Baseline to Month 1 Through Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I', 'description': '0.5 mg ranibizumab driven by visual acuity stability criteria'}, {'id': 'OG001', 'title': 'Group II', 'description': '0.5 mg ranibizumab driven by disease activity criteria'}, {'id': 'OG002', 'title': 'Group III', 'description': 'verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.7', 'spread': '12.65', 'groupId': 'OG000'}, {'value': '54.2', 'spread': '13.01', 'groupId': 'OG001'}, {'value': '52.6', 'spread': '12.29', 'groupId': 'OG002'}]}]}, {'title': 'Average Month 1 to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '64.8', 'spread': '12.82', 'groupId': 'OG000'}, {'value': '65.9', 'spread': '13.26', 'groupId': 'OG001'}, {'value': '61.2', 'spread': '13.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Month 12', 'description': 'Best corrected visual acuity (BCVA) was tested using the ETDRS VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.\n\nBetween treatment comparison of 0.5 mg ranibizumab intravitreal injections driven by disease activity re-treatment criteria (Group II) versus 0.5 mg ranibizumab intravitreal injections driven by visual acuity stability criteria (Group I) based on the average BCVA change from Baseline to Month 1 through Month 12', 'unitOfMeasure': 'ETDRS letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, modified LOCF for comparison between ranibizumab treatment groups.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Visual Acuity Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I', 'description': '0.5 mg ranibizumab driven by visual acuity stability criteria'}, {'id': 'OG001', 'title': 'Group II', 'description': '0.5 mg ranibizumab driven by disease activity criteria'}, {'id': 'OG002', 'title': 'Group III', 'description': 'verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': '9.13', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '10.09', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '9.35', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.6', 'spread': '10.66', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '11.57', 'groupId': 'OG001'}, {'value': '9.5', 'spread': '10.50', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.0', 'spread': '11.50', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '11.46', 'groupId': 'OG001'}, {'value': '10.3', 'spread': '12.69', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at months 3, 6, and 12', 'description': 'Best corrected visual acuity (BCVA) was tested using the ETDRS VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.', 'unitOfMeasure': 'ETDRS letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Categorized BCVA Changes at Months 3, 6 and 12 Compared With Baseline for the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I', 'description': '0.5 mg ranibizumab driven by visual acuity stability criteria'}, {'id': 'OG001', 'title': 'Group II', 'description': '0.5 mg ranibizumab driven by disease activity criteria'}, {'id': 'OG002', 'title': 'Group III', 'description': 'verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment'}], 'classes': [{'title': 'Gained≥15 letters or reached 84 letters-Month 3', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Gained≥10 letters or reached 84 letters-Month 3', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Gained≥15 letters or reached 84 letters-Month 6', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Did not measure for this group as patients randomized to vPDT were allowed to receive ranibizumab from Month 3 onwards.', 'groupId': 'OG002'}]}]}, {'title': 'Gained≥10 letters or reached 84 letters-Month 6', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Did not measure for this group as patients randomized to vPDT were allowed to receive ranibizumab from Month 3 onwards.', 'groupId': 'OG002'}]}]}, {'title': 'Gained≥15 letters or reached 84 letters-Month 12', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Did not measure for this group as patients randomized to vPDT were allowed to receive ranibizumab from Month 3 onwards.', 'groupId': 'OG002'}]}]}, {'title': 'Gained≥10 letters or reached 84 letters-Month 12', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Did not measure for this group as patients randomized to vPDT were allowed to receive ranibizumab from Month 3 onwards.', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to Month 12', 'description': 'ETDRS VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline Over Time in Central Sub-field Thickness (CSFT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I', 'description': '0.5 mg ranibizumab driven by visual acuity stability criteria'}, {'id': 'OG001', 'title': 'Group II', 'description': '0.5 mg ranibizumab driven by disease activity criteria'}, {'id': 'OG002', 'title': 'Group III', 'description': 'verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '-66.4', 'spread': '98.68', 'groupId': 'OG000'}, {'value': '-71.2', 'spread': '81.28', 'groupId': 'OG001'}, {'value': '-29.1', 'spread': '75.57', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '-70.7', 'spread': '73.20', 'groupId': 'OG000'}, {'value': '-75.1', 'spread': '80.90', 'groupId': 'OG001'}, {'value': '-59.3', 'spread': '81.82', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '-79.4', 'spread': '71.39', 'groupId': 'OG000'}, {'value': '-80.8', 'spread': '85.93', 'groupId': 'OG001'}, {'value': '-66.0', 'spread': '93.60', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6, and Month 12', 'description': 'Central sub-field thickness (CSFT) is a variable assessed via Optical Coherence Tomography (OCT). OCT was performed prior to any study drug administration to assess presence of intra, subretinal fluid, or increase of CSFT.', 'unitOfMeasure': 'micrometer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With CNV Leakage (Center Involvement) in the Study Eye at Baseline and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I', 'description': '0.5 mg ranibizumab driven by visual acuity stability criteria'}, {'id': 'OG001', 'title': 'Group II', 'description': '0.5 mg ranibizumab driven by disease activity criteria'}, {'id': 'OG002', 'title': 'Group III', 'description': 'verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment'}], 'classes': [{'title': 'Baseline - Definite', 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}]}, {'title': 'Baseline - Questionable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline - Absent', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': "Baseline - Can't Grade", 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline - Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 - Definite', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 - Questionable', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 - Absent', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}, {'title': "Month 12 - Can't Grade", 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 - Missing', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until Month 12', 'description': "CNV leakage is assessed via fluorescein angiography (center involvement) category: definite, questionable, absent, can't grade, and missing.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'NEI-VFQ-25 - Change From Baseline to Month 3, 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I', 'description': '0.5 mg ranibizumab driven by visual acuity stability criteria'}, {'id': 'OG001', 'title': 'Group II', 'description': '0.5 mg ranibizumab driven by disease activity criteria'}, {'id': 'OG002', 'title': 'Group III', 'description': 'verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '12.28', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '13.49', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '13.55', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '13.40', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '15.42', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '15.30', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '16.03', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '16.92', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '16.85', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at month 3, 6 and 12', 'description': 'The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.', 'unitOfMeasure': 'Composite score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Number of Ranibizumab Injections Received in the Study Eye for the Ranibizumab Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I', 'description': '0.5 mg ranibizumab driven by visual acuity stability criteria'}, {'id': 'OG001', 'title': 'Group II', 'description': '0.5 mg ranibizumab driven by disease activity criteria'}, {'id': 'OG002', 'title': 'Group III With 0.5mg Ranibizumab', 'description': 'verteporfin PDT with 0.5 mg ranibizumab from month 3'}, {'id': 'OG003', 'title': 'Group III Without 0.5mg Ranibizumab', 'description': 'verteporfin PDT without 0.5 mg ranibizumab from month 3'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.84', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Did not measure for this group at month 3', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Did not measure for this group at month 3', 'groupId': 'OG003'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '4.6', 'spread': '2.44', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '2.50', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '2.25', 'groupId': 'OG002'}, {'value': '3.8', 'spread': '2.36', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Month 12', 'description': 'To assess treatment pattern with ranibizumab', 'unitOfMeasure': 'Injections', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set: all patients who received at least one application of study treatment \\& had at least one post-Baseline safety assessment. Patients were analyzed according to treatment received. One patient randomized to vPDT Group III received one ranibizumab injection prior to Month 3; this patient was analyzed under Group II in Safety Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group I', 'description': '0.5 mg ranibizumab driven by visual acuity stability criteria'}, {'id': 'FG001', 'title': 'Group II', 'description': '0.5 mg ranibizumab driven by disease activity criteria'}, {'id': 'FG002', 'title': 'Group III', 'description': 'verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '182'}, {'groupId': 'FG001', 'numSubjects': '184'}, {'groupId': 'FG002', 'numSubjects': '91'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '175'}, {'groupId': 'FG002', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Randomized Set: consisted of all randomized patients. Patients were considered randomized when they had been given a randomization number.', 'preAssignmentDetails': 'In total, 457 patients were randomized into this study in a ratio of 2:2:1: 182 to Group I, 184 to Group II, and 91 to Group III.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '457', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group I', 'description': '0.5 mg ranibizumab driven by visual acuity stability criteria'}, {'id': 'BG001', 'title': 'Group II', 'description': '0.5 mg ranibizumab driven by disease activity criteria'}, {'id': 'BG002', 'title': 'Group III', 'description': 'verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.0', 'spread': '12.01', 'groupId': 'BG000'}, {'value': '51.5', 'spread': '12.13', 'groupId': 'BG001'}, {'value': '49.1', 'spread': '14.81', 'groupId': 'BG002'}, {'value': '51.2', 'spread': '12.68', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '311', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized Set: consisted of all randomized patients. Patients were considered randomized when they had been given a randomization number.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 457}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2016-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-31', 'studyFirstSubmitDate': '2013-08-12', 'resultsFirstSubmitDate': '2017-09-11', 'studyFirstSubmitQcDate': '2013-08-13', 'lastUpdatePostDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-31', 'studyFirstPostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3', 'timeFrame': 'From Baseline to Month 3', 'description': 'Best corrected visual acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) charts testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 6', 'timeFrame': 'From Baseline to Month 6', 'description': 'Best corrected visual acuity (BCVA) was tested using the early treatment diabetic retinopathy study (ETDRS) VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.\n\nBetween treatment comparison of 0.5 mg ranibizumab intravitreal injections driven by disease activity re-treatment criteria (Group II) versus 0.5 mg ranibizumab intravitreal injections driven by visual acuity stability criteria (Group I) based on the average BCVA change from Baseline to Month 1 through Month 6.'}, {'measure': 'The Average Change in BCVA Score From Baseline to Month 1 Through Month 12', 'timeFrame': 'From Baseline to Month 12', 'description': 'Best corrected visual acuity (BCVA) was tested using the ETDRS VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.\n\nBetween treatment comparison of 0.5 mg ranibizumab intravitreal injections driven by disease activity re-treatment criteria (Group II) versus 0.5 mg ranibizumab intravitreal injections driven by visual acuity stability criteria (Group I) based on the average BCVA change from Baseline to Month 1 through Month 12'}, {'measure': 'Mean Change From Baseline in Visual Acuity Over Time', 'timeFrame': 'Change from baseline at months 3, 6, and 12', 'description': 'Best corrected visual acuity (BCVA) was tested using the ETDRS VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.'}, {'measure': 'Categorized BCVA Changes at Months 3, 6 and 12 Compared With Baseline for the Study Eye', 'timeFrame': 'From Baseline to Month 12', 'description': 'ETDRS VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.'}, {'measure': 'Mean Change From Baseline Over Time in Central Sub-field Thickness (CSFT)', 'timeFrame': 'Baseline, Month 3, Month 6, and Month 12', 'description': 'Central sub-field thickness (CSFT) is a variable assessed via Optical Coherence Tomography (OCT). OCT was performed prior to any study drug administration to assess presence of intra, subretinal fluid, or increase of CSFT.'}, {'measure': 'Number of Patients With CNV Leakage (Center Involvement) in the Study Eye at Baseline and Month 12', 'timeFrame': 'From Baseline until Month 12', 'description': "CNV leakage is assessed via fluorescein angiography (center involvement) category: definite, questionable, absent, can't grade, and missing."}, {'measure': 'NEI-VFQ-25 - Change From Baseline to Month 3, 6 and 12', 'timeFrame': 'Change from baseline at month 3, 6 and 12', 'description': 'The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.'}, {'measure': 'Number of Ranibizumab Injections Received in the Study Eye for the Ranibizumab Groups', 'timeFrame': 'From Baseline to Month 12', 'description': 'To assess treatment pattern with ranibizumab'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vision loss,PM,CNV,ranibizumab,verteporfinPDT,Brilliance'], 'conditions': ['Visual Impairment Due to Choroidal Neovascularization (CNV) Secondary to Pathologic Myopia (PM)']}, 'descriptionModule': {'briefSummary': 'This study was designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization secondary to pathologic myopia (PM)', 'detailedDescription': 'This was a phase III, multi-center, randomized, double-masked, active-controlled study comparing 0.5 mg ranibizumab vs. vPDT therapy. The study included 15 scheduled visits over 12 months, and there were to be two additional visits (2a, 3a) for subset of patients in whom PK analysis were performed.\n\nThere were 3 periods in this study: Screening period-from Day -14 to Baseline; Treatment period-from Baseline to Month 11; Follow-up period-from Month 11 to Month 12 Patients entered the 11 months Treatment period at Visit 2 (Day 1) if eligibility criteria were met and were randomized in three treatment groups Group I ranibizumab 0.5 mg driven by VA stability criteria or Group II ranibizumab 0.5 mg driven by disease activity criteria or Group III vPDT (randomization ratio of 2:2:1) and received first treatment of either a ranibizumab injection and sham vPDT or sham injection and active vPDT and will return to the clinical center within 7 days to undergo safety assessments as well as assessments of the effect of treatment by the evaluating investigator. The following visits were performed at one month intervals starting at Visit 4 and continuing through Visit 14. At all monthly visits (at/from Month 2 for group I, at/from Month 1 for group II and at/from Month 3 for group III) the decision for treatment were made by the evaluating investigator based on the VA stability criteria and on the disease activity criteria. At Month 3 (visit 6) and at all following monthly visits for all three groups one of the three options can recommended by evaluating investigator: a) ranibizumab 0.5 mg, b) ranibizumab 0.5 mg + vPDT; c) vPDT. The treating investigator were then perform treatment based on randomization and masking requirements.\n\nAt each monthly visit, patients had a safety evaluation by the evaluating investigator prior to study treatment, consisting of visual acuity measurements, ophthalmic examinations and evaluation of adverse events and vital signs. Routine hematology, chemistry, and urinalysis profiles were obtained at Visit 6, 9 and 12 (Month 3, 6 and 9). At Month 12 several procedures and assessments were performed which are required at study completion visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Visual impairment due to CNV secondary to PM.\n* Best corrected visual acuity in the study eye \\> 24 and \\< 78 ETDRS letters.\n* High myopia (\\> -6D),\n* anterio-posterior elongation \\> 26 mm; posterior changes compatible with the pathologic myopia.\n* Either CNV locations in the study eye: subfoveal, juxtafoveal, extrafoveal.\n\nExclusion Criteria:\n\n* Some preexisting eye disorders or systemic diseases;-Blood pressure \\> 150/90 mmHg\n* Prior focal/grid laser to the macular area -History of treatment with any anti-VEGF or verteporfin PDT in the study eye\n* Intravitreal treatment with corticosteroids or intraocular surgery within last 3 months in the study eye'}, 'identificationModule': {'nctId': 'NCT01922102', 'acronym': 'Brilliance', 'briefTitle': 'Efficacy and Safety of Ranibizumab 0.5 vs Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 12-month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Individualized Regimens of 0.5mg Ranibizumab vs. Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia', 'orgStudyIdInfo': {'id': 'CRFB002F2302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': '0.5 mg ranibizumab driven by visual acuity stability criteria', 'interventionNames': ['Drug: Ranibizumab 0.5mg']}, {'type': 'EXPERIMENTAL', 'label': 'Group II', 'description': '0.5 mg ranibizumab driven by disease activity criteria', 'interventionNames': ['Drug: Ranibizumab 0.5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III', 'description': 'verteporfin PDT', 'interventionNames': ['Drug: Verteporfin PDT']}], 'interventions': [{'name': 'Ranibizumab 0.5mg', 'type': 'DRUG', 'otherNames': ['Lucentis'], 'description': '0.5 mg ranibizumab (intravitreal injections)', 'armGroupLabels': ['Group I']}, {'name': 'Ranibizumab 0.5 mg', 'type': 'DRUG', 'otherNames': ['Lucentis'], 'description': '0.5 mg ranibizumab (intravitreal injections)', 'armGroupLabels': ['Group II']}, {'name': 'Verteporfin PDT', 'type': 'DRUG', 'otherNames': ['Visudyne'], 'description': 'Verteporfin for intravenous injection delivered by intravenous infusion followed by the light application', 'armGroupLabels': ['Group III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 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'Thailand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'zip': '73210', 'city': 'Nakornphathom', 'country': 'Thailand', 'facility': 'Novartis Investigative Site'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}