Viewing Study NCT02366468

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Ignite Creation Date: 2025-12-24 @ 5:53 PM
Ignite Modification Date: 2026-02-22 @ 5:14 AM
Study NCT ID: NCT02366468
Status: COMPLETED
Last Update Posted: 2019-01-04
First Post: 2015-01-12
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Study of Efficacy of Ranibizumab in Different Regimens in Patients With Diabetic Macula Edema
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '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': 'From start of study treatment until month 12', 'eventGroups': [{'id': 'EG000', 'title': 'Discretion of the Investigator (DI)', 'description': 'Investigational - ranibizumab 0.5 mg', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 44, 'seriousNumAtRisk': 68, 'deathsNumAffected': 1, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Pro re Nata (PRN)', 'description': 'Standard of Care - ranibizumab 0.5 mg', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 43, 'seriousNumAtRisk': 67, 'deathsNumAffected': 2, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Corneal erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Foreign body sensation in eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Ocular discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Glycosylated haemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'seriousEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Heart valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Eyelid function disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'VIIth nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Urinary nitrogen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Acoustic neuroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Chronic myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': "Behcet's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Discretion of the Investigator (DI)', 'description': 'Investigational - ranibizumab 0.5 mg'}, {'id': 'OG001', 'title': 'Pro re Nata (PRN)', 'description': 'Standard of Care - ranibizumab 0.5 mg'}], 'classes': [{'title': 'Baseline (Day 1)', 'categories': [{'measurements': [{'value': '67.4', 'spread': '9.52', 'groupId': 'OG000'}, {'value': '65.1', 'spread': '9.59', 'groupId': 'OG001'}]}]}, {'title': 'post baseline average over month 1 to month 12', 'categories': [{'measurements': [{'value': '73.5', 'spread': '9.50', 'groupId': 'OG000'}, {'value': '73.8', 'spread': '7.75', 'groupId': 'OG001'}]}]}, {'title': 'Visit-averaged change from baseline', 'categories': [{'measurements': [{'value': '6.1', 'spread': '6.54', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '6.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-3.04', 'ciUpperLimit': '1.27', 'groupDescription': 'The primary objective was to demonstrate that the mean visit-averaged change from baseline of BCVA over month 1 to treatment completion for the DI arm was non-inferior to the PRN arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'including study treatment (DI, PRN) and center as factors and baseline BCVA as continuous covariate.', 'nonInferiorityComment': 'non-inferiority margin: -4 letters'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12', 'description': 'BCVA was assessed as letters read using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The mean average change from baseline was defined as the difference between the average level of BCVA (ETDRS letters) over all post-baseline assessments from Month 1 to Month 12. A positive change represents an improvement in visual acuity', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Last Observation Carried Forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Number of Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Discretion of the Investigator (DI)', 'description': 'Investigational - ranibizumab 0.5 mg'}, {'id': 'OG001', 'title': 'Pro re Nata (PRN)', 'description': 'Standard of Care - ranibizumab 0.5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '2.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 12', 'description': 'Mean number of visits during the study', 'unitOfMeasure': 'Visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Number of Injections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Discretion of the Investigator (DI)', 'description': 'Investigational - ranibizumab 0.5 mg'}, {'id': 'OG001', 'title': 'Pro re Nata (PRN)', 'description': 'Standard of Care - ranibizumab 0.5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '3.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 12', 'description': 'mean number of injections in the study eye during the study', 'unitOfMeasure': 'Injections', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Free Intervals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Discretion of the Investigator (DI)', 'description': 'Investigational - ranibizumab 0.5 mg'}, {'id': 'OG001', 'title': 'Pro re Nata (PRN)', 'description': 'Standard of Care - ranibizumab 0.5 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 12', 'description': 'A treatment-free interval is the interval between the first NO treatment given when the reason for NO treatment given is one of the three stability criteria and the first subsequent YES treatment given after that.', 'unitOfMeasure': 'Intervals', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - including only patients with at least one treatment-free interval'}, {'type': 'SECONDARY', 'title': 'Mean Change in Central Subfield Retinal Thickness (CSRT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Discretion of the Investigator (DI)', 'description': 'Investigational - ranibizumab 0.5 mg'}, {'id': 'OG001', 'title': 'Pro re Nata (PRN)', 'description': 'Standard of Care - ranibizumab 0.5 mg'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '420.0', 'spread': '114.98', 'groupId': 'OG000'}, {'value': '431.0', 'spread': '128.13', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 (LOCF)', 'categories': [{'measurements': [{'value': '313.3', 'spread': '61.21', 'groupId': 'OG000'}, {'value': '320.6', 'spread': '85.27', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Month 12 (LOCF)', 'categories': [{'measurements': [{'value': '-106.7', 'spread': '109.58', 'groupId': 'OG000'}, {'value': '-110.4', 'spread': '101.97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.620', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.7', 'ciLowerLimit': '-17.10', 'ciUpperLimit': '28.56', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'containing the baseline values of the dependent variables as continuous covariates, and center and treatment as categorical covariates'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 12', 'description': 'Evaluated by central reading center assessing OCT images', 'unitOfMeasure': 'μm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Last Observation Carried Forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Mean Change of Foveal Center Point Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Discretion of the Investigator (DI)', 'description': 'Investigational - ranibizumab 0.5 mg'}, {'id': 'OG001', 'title': 'Pro re Nata (PRN)', 'description': 'Standard of Care - ranibizumab 0.5 mg'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '398.8', 'spread': '144.10', 'groupId': 'OG000'}, {'value': '405.0', 'spread': '138.06', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 - LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '273.3', 'spread': '84.85', 'groupId': 'OG000'}, {'value': '280.6', 'spread': '105.44', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Month 12 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-125.6', 'spread': '142.69', 'groupId': 'OG000'}, {'value': '-124.4', 'spread': '113.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.925', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-33.66', 'ciUpperLimit': '30.59', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'containing the baseline values of the dependent variables as continuous covariates, and center and treatment as categorical covariates'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 12', 'description': 'Evaluated by central reading center assessing OCT images', 'unitOfMeasure': 'μm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - LOCF - including only patients with assessments'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Discretion of the Investigator (DI)', 'description': 'Investigational - ranibizumab 0.5 mg'}, {'id': 'OG001', 'title': 'Pro re Nata (PRN)', 'description': 'Standard of Care - ranibizumab 0.5 mg'}], 'classes': [{'categories': [{'title': '> 2 steps improvement', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': '2 steps improvement', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': '1 step improvement', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '0 steps', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'title': '1 step loss', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': '2 steps loss', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '> 2 steps loss', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Month 12', 'description': 'Evaluated by central reading center scoring fundus photography', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - LOCF - including only patients with assessments'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Discretion of the Investigator (DI)', 'description': 'Investigational - ranibizumab 0.5 mg'}, {'id': 'FG001', 'title': 'Pro re Nata (PRN)', 'description': 'Standard of Care - ranibizumab 0.5 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized Safety Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'Full Analysis Set (FAS)', 'comment': 'Randomized patients who received study treatment and had post-baseline primary endpoint assessments', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'Per Protocol Set (PPS)', 'comment': 'All patients in the FAS who completed the trial without major protocol deviations', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'a total of 135 patients were randomized and assigned in a 1:1 ratio to the treatment arms.', 'preAssignmentDetails': 'At Screening, the eligibility criteria were performed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Discretion of the Investigator (DI)', 'description': 'Investigational - ranibizumab 0.5 mg'}, {'id': 'BG001', 'title': 'Pro re Nata (PRN)', 'description': 'Standard of Care - ranibizumab 0.5 mg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.6', 'spread': '13.73', 'groupId': 'BG000'}, {'value': '65.0', 'spread': '10.37', 'groupId': 'BG001'}, {'value': '63.8', 'spread': '12.19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'FAS'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'FAS'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS). All patients randomized who received at least one application of study treatment and had at least one post-baseline assessment for the primary endpoint (BCVA).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-18', 'size': 317311, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-05T08:09', 'hasProtocol': True}, {'date': '2018-02-13', 'size': 634820, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-06-05T08:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-01', 'studyFirstSubmitDate': '2015-01-12', 'resultsFirstSubmitDate': '2018-06-05', 'studyFirstSubmitQcDate': '2015-02-11', 'lastUpdatePostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-01', 'studyFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12)', 'timeFrame': 'Baseline, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12', 'description': 'BCVA was assessed as letters read using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The mean average change from baseline was defined as the difference between the average level of BCVA (ETDRS letters) over all post-baseline assessments from Month 1 to Month 12. A positive change represents an improvement in visual acuity'}], 'secondaryOutcomes': [{'measure': 'Number of Visits', 'timeFrame': 'Baseline to Month 12', 'description': 'Mean number of visits during the study'}, {'measure': 'Number of Injections', 'timeFrame': 'Baseline to Month 12', 'description': 'mean number of injections in the study eye during the study'}, {'measure': 'Number of Treatment Free Intervals', 'timeFrame': 'Baseline to Month 12', 'description': 'A treatment-free interval is the interval between the first NO treatment given when the reason for NO treatment given is one of the three stability criteria and the first subsequent YES treatment given after that.'}, {'measure': 'Mean Change in Central Subfield Retinal Thickness (CSRT)', 'timeFrame': 'Baseline to Month 12', 'description': 'Evaluated by central reading center assessing OCT images'}, {'measure': 'Mean Change of Foveal Center Point Thickness', 'timeFrame': 'Baseline to Month 12', 'description': 'Evaluated by central reading center assessing OCT images'}, {'measure': 'Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale', 'timeFrame': 'Baseline to Month 12', 'description': 'Evaluated by central reading center scoring fundus photography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic macular edema', 'Visual impairment'], 'conditions': ['Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to demonstrate that the change of best corrected visual acuity (BCVA) was comparable in patients treated with ranibizumab at the discretion of the investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤ 12.0%\n* Patients with visual impairment due to DME in at least one eye\n* BCVA ≥ 24 and ≤ 78 letters in the study eye\n\nExclusion Criteria:\n\n* Active intraocular inflammation\n* Any active infection in either eye at the\n* Structural damage within 0.5 disc diameter of the center of the macula in the study eye\n* Uncontrolled glaucoma in either eye at screening\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02366468', 'acronym': 'DIVERSE', 'briefTitle': 'Study of Efficacy of Ranibizumab in Different Regimens in Patients With Diabetic Macula Edema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 12-months, Randomized, VA-assessor Blinded, Multicenter, Controlled Phase IV Trial to Investigate Noninferiority of Two Treatment Algorithms (Discretion of the Investigator vs. Pro re Nata) of 0.5 mg Ranibizumab in Patients With Visual Impairment Due to Diabetic Macula Edema', 'orgStudyIdInfo': {'id': 'CRFB002DDE26'}, 'secondaryIdInfos': [{'id': '2014-002854-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Discretion of the investigator (DI)', 'description': 'ranibizumab 0.5 mg, after initial monthly treatment until maximum BCVA and no signs or no further change of disease activity, the investigator treated patients at their own discretion. 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