Viewing Study NCT04058067

Home

Certify Doc

Genes

Clinical Trials

CompTox

DrugMatrix

Open Targets

Products

Support

Bugs

Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 12:31 AM

Ignite Modification Date: 2026-02-24 @ 8:25 AM

Study NCT ID: NCT04058067

Status: COMPLETED

Last Update Posted: 2024-10-09

First Post: 2019-08-14

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: To Compare Brolucizumab to Aflibercept in Chinese Patients With Visual Impairment Due to Diabetic Macular 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': 'D008269', 'term': 'Macular Edema'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000622091', 'term': 'brolucizumab'}, {'id': 'C533178', 'term': 'aflibercept'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@Novartis.com', 'phone': '+ 1 862 778 8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events are reported from first dose of study treatment until end of study, up to a maximum duration of approximately 52 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Brolucizumab 6mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance', 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 92, 'seriousNumAtRisk': 132, 'deathsNumAffected': 0, 'seriousNumAffected': 28}, {'id': 'EG001', 'title': 'Aflibercept 2mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance', 'otherNumAtRisk': 131, 'deathsNumAtRisk': 131, 'otherNumAffected': 84, 'seriousNumAtRisk': 131, 'deathsNumAffected': 1, 'seriousNumAffected': 22}, {'id': 'EG002', 'title': 'Overall', 'description': 'Overall', 'otherNumAtRisk': 263, 'deathsNumAtRisk': 263, 'otherNumAffected': 176, 'seriousNumAtRisk': 263, 'deathsNumAffected': 1, 'seriousNumAffected': 50}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cataract - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cataract - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Conjunctival haemorrhage - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Conjunctival haemorrhage - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Diabetic retinal oedema - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 15}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Diabetic retinopathy - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dry eye - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dry eye - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Epiretinal membrane - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Eye pruritus - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Eye pruritus - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Macular oedema - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Meibomian gland dysfunction - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 17}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Meibomian gland dysfunction - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 17}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Uveitis - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Visual acuity reduced - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 18}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Visual acuity reduced - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 18}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Vitreous haemorrhage - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Vitreous opacities - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Vitreous opacities - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Xerophthalmia - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Xerophthalmia - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hepatic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Bacterial test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Blood urea nitrogen/creatinine ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Intraocular pressure increased - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Intraocular pressure increased - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'White blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypoproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Carotid arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Diabetic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Aortic arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 19}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cataract - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cataract - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cataract nuclear - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Diabetic retinal oedema - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Retinal artery occlusion - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Vitreous haemorrhage - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Diabetic gastroparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Oesophageal varices haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Contrast media allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Endophthalmitis - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Comminuted fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Traumatic intracranial haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Bone cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Colorectal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cerebrovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Diabetic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'End stage renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Blood pressure inadequately controlled', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Subclavian artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline at Week 52 in Best-corrected Visual Acuity (BCVA) for the Study Eye.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.20', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set- last observation carried forward (FAS - LOCF)'}, {'type': 'PRIMARY', 'title': 'Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 40 Through Week 52 for the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.15', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 40 to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set- last observation carried forward (FAS - LOCF)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline by Visit up to Week 52 in Best-corrected Visual Acuity (BCVA) for the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 4 (n=129,123)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '6.58', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '6.75', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=125,122)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '7.49', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '7.50', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=128,125)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.6', 'spread': '8.43', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '8.56', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=119,122)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '8.77', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '9.67', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=115,118)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'spread': '9.83', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '9.86', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 (n=113,115)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.8', 'spread': '9.19', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '10.25', 'groupId': 'OG001'}]}]}, {'title': 'Week 20 (n=109,114)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'spread': '9.36', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '9.57', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n=109,116)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.9', 'spread': '10.48', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '9.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 28 (n=111,111)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': '9.62', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '10.13', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 (n=107,116)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.1', 'spread': '10.29', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '10.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 (n=105,114)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'spread': '10.86', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '10.62', 'groupId': 'OG001'}]}]}, {'title': 'Week 40 (n=101,110)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.1', 'spread': '10.24', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '10.02', 'groupId': 'OG001'}]}]}, {'title': 'Week 44 (n=102,110)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.2', 'spread': '9.86', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '9.79', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 (n=103,105)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.9', 'spread': '9.91', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '10.71', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=105,105)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.3', 'spread': '9.21', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '10.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set- observed. All randomized subjects who received at least one intravitreal treatment (IVT) injection of the study treatment and had a valid value of the outcome measure at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 4 Through Week 52 for the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '0.68', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.96', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 4 to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set- last observation carried forward (FAS - LOCF)'}, {'type': 'SECONDARY', 'title': 'Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 20 Through Week 52 for the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '0.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.09', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 20 to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set- last observation carried forward (FAS - LOCF)'}, {'type': 'SECONDARY', 'title': 'Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 28 Through Week 52 for the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '0.80', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.14', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 28 to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set- last observation carried forward (FAS - LOCF)'}, {'type': 'SECONDARY', 'title': 'Time-to-first q8w Treatment Need: Summary for Brolucizumab Subjects by Disease Activity Assessment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'comment': 'Not applicable for probability of 1', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 32 (n=86,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.733', 'groupId': 'OG000', 'lowerLimit': '0.626', 'upperLimit': '0.813'}]}]}, {'title': 'Week36 (n=59,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.447', 'groupId': 'OG000', 'lowerLimit': '0.338', 'upperLimit': '0.550'}]}]}, {'title': 'Week48 (n=30,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.417', 'groupId': 'OG000', 'lowerLimit': '0.309', 'upperLimit': '0.522'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0), Week 32, Week 36 and Week 48', 'description': "The estimate for the proportion of subjects with a positive q12w treatment status was derived from Kaplan Meier time-to-event analyses for the event 'first q8w-need', applying a 'q8w-need' allocation in case of missing or confounded data attributable to lack of efficacy and/or lack of safety. As a result, the probability that subjects in brolucizumab arm do not need a q8w treatment (and therefore are maintained on a q12w treatment) up to the visit is reported in the table.", 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Efficacy/Safety approach'}, {'type': 'SECONDARY', 'title': 'Time-to-first q8w Treatment Need: Summary for Brolucizumab Subjects by Disease Activity Assessment Visit, Within Those Subjects With no q8w-need During the Initial q12w Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week36 (n=35,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'comment': 'Not applicable for probability of 1', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week48 (n=29,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.931', 'groupId': 'OG000', 'lowerLimit': '0.751', 'upperLimit': '0.982'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36 and Week 48', 'description': "The estimate for the proportion of subjects with a positive q12w treatment status was derived from Kaplan Meier time-to-event analyses for the event 'first q8w-need', applying a 'q8w-need' allocation in case of missing or confounded data attributable to lack of efficacy and/or lack of safety. As a result, the probability that subjects in brolucizumab arm do not need a q8w treatment (and therefore are maintained on a q12w treatment) up to the visit is reported in the table.", 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Efficacy/Safety approach. Participants in the Full Analysis Set with no identified q8w-need at Week 32 and Week 36.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of Patients Who Gained in ≥5, ≥10 and ≥15 ETDRS Letters in BCVA From Baseline to Week 52 for the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'N (%) of subjects with ≥5 letters gain from baseline or reached BCVA of ≥84 letters at Week 52', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}, {'title': 'N (%) of subjects with ≥10 letters gain from baseline or reached BCVA of ≥84 letters at Week 52', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'N (%) of subjects with ≥15 letters gain from baseline or reached BCVA of ≥84 letters at Week 52', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'DIfference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.0', 'ciLowerLimit': '-13.7', 'ciUpperLimit': '6.7', 'groupDescription': 'Proportion of subjects with ≥5 letters gain from baseline or reached BCVA of ≥84 letters at Week 52', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-14.7', 'ciUpperLimit': '9.4', 'groupDescription': 'Proportion of subjects with ≥10 letters gain from baseline or reached BCVA of ≥84 letters at Week 52', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-15.5', 'ciUpperLimit': '6.9', 'groupDescription': 'Proportion of subjects with ≥15 letters gain from baseline or reached BCVA of ≥84 letters at Week 52', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set- last observation carried forward (FAS - LOCF)'}, {'type': 'SECONDARY', 'title': 'Time to Achieve Gain of >= 5 Letters in BCVA From Baseline or Reach BCVA >=84 Letters for the Study Eye - Probability of BCVA Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.136', 'groupId': 'OG000', 'lowerLimit': '0.084', 'upperLimit': '0.201'}, {'value': '0.038', 'groupId': 'OG001', 'lowerLimit': '0.014', 'upperLimit': '0.081'}]}]}, {'title': 'Week 6 (n=114,126)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.508', 'groupId': 'OG000', 'lowerLimit': '0.419', 'upperLimit': '0.589'}, {'value': '0.420', 'groupId': 'OG001', 'lowerLimit': '0.334', 'upperLimit': '0.503'}]}]}, {'title': 'Week 8 (n=65, 76)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.720', 'groupId': 'OG000', 'lowerLimit': '0.634', 'upperLimit': '0.789'}, {'value': '0.634', 'groupId': 'OG001', 'lowerLimit': '0.544', 'upperLimit': '0.710'}]}]}, {'title': 'Week 12 (n=37, 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.780', 'groupId': 'OG000', 'lowerLimit': '0.699', 'upperLimit': '0.842'}, {'value': '0.725', 'groupId': 'OG001', 'lowerLimit': '0.639', 'upperLimit': '0.794'}]}]}, {'title': 'Week 16 (n=29, 36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.818', 'groupId': 'OG000', 'lowerLimit': '0.740', 'upperLimit': '0.875'}, {'value': '0.780', 'groupId': 'OG001', 'lowerLimit': '0.697', 'upperLimit': '0.842'}]}]}, {'title': 'Week 18 (n=24, 28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.818', 'groupId': 'OG000', 'lowerLimit': '0.740', 'upperLimit': '0.875'}, {'value': '0.843', 'groupId': 'OG001', 'lowerLimit': '0.766', 'upperLimit': '0.896'}]}]}, {'title': 'Week 20 (n=24,20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.841', 'groupId': 'OG000', 'lowerLimit': '0.765', 'upperLimit': '0.894'}, {'value': '0.866', 'groupId': 'OG001', 'lowerLimit': '0.793', 'upperLimit': '0.915'}]}]}, {'title': 'Week 24 (n=21,17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.856', 'groupId': 'OG000', 'lowerLimit': '0.782', 'upperLimit': '0.906'}, {'value': '0.874', 'groupId': 'OG001', 'lowerLimit': '0.802', 'upperLimit': '0.921'}]}]}, {'title': 'Week 28 (n=19,15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.864', 'groupId': 'OG000', 'lowerLimit': '0.791', 'upperLimit': '0.913'}, {'value': '0.882', 'groupId': 'OG001', 'lowerLimit': '0.811', 'upperLimit': '0.928'}]}]}, {'title': 'Week 32 (n=17,14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.888', 'groupId': 'OG000', 'lowerLimit': '0.818', 'upperLimit': '0.932'}, {'value': '0.882', 'groupId': 'OG001', 'lowerLimit': '0.811', 'upperLimit': '0.928'}]}]}, {'title': 'Week 36 (n=14,14,)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.888', 'groupId': 'OG000', 'lowerLimit': '0.818', 'upperLimit': '0.932'}, {'value': '0.882', 'groupId': 'OG001', 'lowerLimit': '0.811', 'upperLimit': '0.928'}]}]}, {'title': 'Week 40 (n=14,14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.888', 'groupId': 'OG000', 'lowerLimit': '0.818', 'upperLimit': '0.932'}, {'value': '0.908', 'groupId': 'OG001', 'lowerLimit': '0.840', 'upperLimit': '0.948'}]}]}, {'title': 'Week 44 (n=14,11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.896', 'groupId': 'OG000', 'lowerLimit': '0.828', 'upperLimit': '0.938'}, {'value': '0.908', 'groupId': 'OG001', 'lowerLimit': '0.840', 'upperLimit': '0.948'}]}]}, {'title': 'Week 48 (n=13,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.912', 'groupId': 'OG000', 'lowerLimit': '0.846', 'upperLimit': '0.951'}, {'value': '0.917', 'groupId': 'OG001', 'lowerLimit': '0.850', 'upperLimit': '0.955'}]}]}, {'title': 'Week 52 (n=11,9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.957', 'groupId': 'OG000', 'lowerLimit': '0.880', 'upperLimit': '0.985'}, {'value': '0.926', 'groupId': 'OG001', 'lowerLimit': '0.860', 'upperLimit': '0.962'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.', 'unitOfMeasure': 'Probability of BCVA gain', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Time to Achieve Gain of >= 10 Letters in BCVA From Baseline or Reach BCVA >=84 Letters for the Study Eye - Probability of BCVA Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.061', 'groupId': 'OG000', 'lowerLimit': '0.028', 'upperLimit': '0.110'}, {'value': '0.000', 'comment': 'CI is NA when probability is 0.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 6 (n=124,131)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.227', 'groupId': 'OG000', 'lowerLimit': '0.160', 'upperLimit': '0.302'}, {'value': '0.198', 'groupId': 'OG001', 'lowerLimit': '0.135', 'upperLimit': '0.271'}]}]}, {'title': 'Week 8 (n=102,105)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.394', 'groupId': 'OG000', 'lowerLimit': '0.310', 'upperLimit': '0.476'}, {'value': '0.306', 'groupId': 'OG001', 'lowerLimit': '0.229', 'upperLimit': '0.386'}]}]}, {'title': 'Week 12 (n=80,90)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.508', 'groupId': 'OG000', 'lowerLimit': '0.419', 'upperLimit': '0.590'}, {'value': '0.439', 'groupId': 'OG001', 'lowerLimit': '0.352', 'upperLimit': '0.523'}]}]}, {'title': 'Week 16 (n=64,71)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.562', 'groupId': 'OG000', 'lowerLimit': '0.472', 'upperLimit': '0.642'}, {'value': '0.527', 'groupId': 'OG001', 'lowerLimit': '0.436', 'upperLimit': '0.609'}]}]}, {'title': 'Week 18 (n=55,59)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.594', 'groupId': 'OG000', 'lowerLimit': '0.504', 'upperLimit': '0.673'}, {'value': '0.551', 'groupId': 'OG001', 'lowerLimit': '0.460', 'upperLimit': '0.633'}]}]}, {'title': 'Week 20 (n=50,56)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.618', 'groupId': 'OG000', 'lowerLimit': '0.528', 'upperLimit': '0.696'}, {'value': '0.591', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '0.671'}]}]}, {'title': 'Week 24 (n=47,51)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.643', 'groupId': 'OG000', 'lowerLimit': '0.553', 'upperLimit': '0.719'}, {'value': '0.664', 'groupId': 'OG001', 'lowerLimit': '0.573', 'upperLimit': '0.739'}]}]}, {'title': 'Week 28 (n=44,41)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.659', 'groupId': 'OG000', 'lowerLimit': '0.570', 'upperLimit': '0.735'}, {'value': '0.680', 'groupId': 'OG001', 'lowerLimit': '0.590', 'upperLimit': '0.754'}]}]}, {'title': 'Week 32 (n=41,38)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.676', 'groupId': 'OG000', 'lowerLimit': '0.587', 'upperLimit': '0.750'}, {'value': '0.705', 'groupId': 'OG001', 'lowerLimit': '0.616', 'upperLimit': '0.777'}]}]}, {'title': 'Week 36 (n=39,35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.693', 'groupId': 'OG000', 'lowerLimit': '0.604', 'upperLimit': '0.766'}, {'value': '0.722', 'groupId': 'OG001', 'lowerLimit': '0.634', 'upperLimit': '0.793'}]}]}, {'title': 'Week 40 (n=35,33)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.710', 'groupId': 'OG000', 'lowerLimit': '0.622', 'upperLimit': '0.782'}, {'value': '0.730', 'groupId': 'OG001', 'lowerLimit': '0.642', 'upperLimit': '0.800'}]}]}, {'title': 'Week 44 (n=33,32)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.728', 'groupId': 'OG000', 'lowerLimit': '0.640', 'upperLimit': '0.798'}, {'value': '0.739', 'groupId': 'OG001', 'lowerLimit': '0.652', 'upperLimit': '0.808'}]}]}, {'title': 'Week 48 (n=31,28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.754', 'groupId': 'OG000', 'lowerLimit': '0.667', 'upperLimit': '0.822'}, {'value': '0.749', 'groupId': 'OG001', 'lowerLimit': '0.661', 'upperLimit': '0.817'}]}]}, {'title': 'Week 52 (n=28,27)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.899', 'groupId': 'OG000', 'lowerLimit': '0.416', 'upperLimit': '0.987'}, {'value': '1', 'comment': 'CI is NA when probability = 1.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.', 'unitOfMeasure': 'Probability of BCVA gain', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Time to Achieve Gain of >= 15 Letters in BCVA From Baseline or Reach BCVA >=84 Letters for the Study Eye - Probability of BCVA Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.008', 'groupId': 'OG000', 'lowerLimit': '0.001', 'upperLimit': '0.038'}, {'value': '0.000', 'comment': 'CI is NA when probability = 0.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 6 (n=131,131)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.083', 'groupId': 'OG000', 'lowerLimit': '0.044', 'upperLimit': '0.138'}, {'value': '0.069', 'groupId': 'OG001', 'lowerLimit': '0.034', 'upperLimit': '0.121'}]}]}, {'title': 'Week 8 (n=121,122)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.152', 'groupId': 'OG000', 'lowerLimit': '0.096', 'upperLimit': '0.218'}, {'value': '0.161', 'groupId': 'OG001', 'lowerLimit': '0.104', 'upperLimit': '0.229'}]}]}, {'title': 'Week 12 (n=112,109)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.227', 'groupId': 'OG000', 'lowerLimit': '0.160', 'upperLimit': '0.302'}, {'value': '0.216', 'groupId': 'OG001', 'lowerLimit': '0.149', 'upperLimit': '0.290'}]}]}, {'title': 'Week 16 (n=101,100)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.266', 'groupId': 'OG000', 'lowerLimit': '0.193', 'upperLimit': '0.343'}, {'value': '0.255', 'groupId': 'OG001', 'lowerLimit': '0.183', 'upperLimit': '0.333'}]}]}, {'title': 'Week 18 (n=94,94)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.313', 'groupId': 'OG000', 'lowerLimit': '0.235', 'upperLimit': '0.393'}, {'value': '0.319', 'groupId': 'OG001', 'lowerLimit': '0.240', 'upperLimit': '0.401'}]}]}, {'title': 'Week 20 (n=87,85)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.344', 'groupId': 'OG000', 'lowerLimit': '0.264', 'upperLimit': '0.426'}, {'value': '0.359', 'groupId': 'OG001', 'lowerLimit': '0.276', 'upperLimit': '0.442'}]}]}, {'title': 'Week 24 (n=82,80)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.409', 'groupId': 'OG000', 'lowerLimit': '0.323', 'upperLimit': '0.492'}, {'value': '0.399', 'groupId': 'OG001', 'lowerLimit': '0.313', 'upperLimit': '0.483'}]}]}, {'title': 'Week 28 (n=72,74)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.425', 'groupId': 'OG000', 'lowerLimit': '0.338', 'upperLimit': '0.509'}, {'value': '0.432', 'groupId': 'OG001', 'lowerLimit': '0.344', 'upperLimit': '0.516'}]}]}, {'title': 'Week 32 (n=67,69)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.459', 'groupId': 'OG000', 'lowerLimit': '0.370', 'upperLimit': '0.544'}, {'value': '0.456', 'groupId': 'OG001', 'lowerLimit': '0.367', 'upperLimit': '0.541'}]}]}, {'title': 'Week 36 (n=63,66)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.485', 'groupId': 'OG000', 'lowerLimit': '0.395', 'upperLimit': '0.570'}, {'value': '0.481', 'groupId': 'OG001', 'lowerLimit': '0.391', 'upperLimit': '0.566'}]}]}, {'title': 'Week 40 (n=58,63)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.494', 'groupId': 'OG000', 'lowerLimit': '0.403', 'upperLimit': '0.579'}, {'value': '0.506', 'groupId': 'OG001', 'lowerLimit': '0.415', 'upperLimit': '0.590'}]}]}, {'title': 'Week 44 (n=57,60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.512', 'groupId': 'OG000', 'lowerLimit': '0.420', 'upperLimit': '0.596'}, {'value': '0.531', 'groupId': 'OG001', 'lowerLimit': '0.439', 'upperLimit': '0.614'}]}]}, {'title': 'Week 48 (n=55,54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.539', 'groupId': 'OG000', 'lowerLimit': '0.446', 'upperLimit': '0.622'}, {'value': '0.540', 'groupId': 'OG001', 'lowerLimit': '0.447', 'upperLimit': '0.623'}]}]}, {'title': 'Week 52 (n=52,53)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.623', 'groupId': 'OG000', 'lowerLimit': '0.436', 'upperLimit': '0.763'}, {'value': '1', 'comment': 'CI is NA when probability = 1.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.', 'unitOfMeasure': 'Probability of BCVA gain', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of Patients Who Lost ≥5, ≥10 and ≥15 ETDRS Letters in BCVA From Baseline to Week 52 for the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'N (%) of subjects with ≥5 letters loss from baseline or reached BCVA of ≥84 letters at Week 52', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'N (%) of subjects with ≥10 letters loss from baseline or reached BCVA of ≥84 letters at Week 52', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'N (%) of subjects with ≥15 letters loss from baseline or reached BCVA of ≥84 letters at Week 52', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'DIfference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '4.4', 'groupDescription': 'Proportion of subjects with ≥5 letters loss from baseline at Week 52', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '3.8', 'groupDescription': 'Proportion of subjects with ≥10 letters loss from baseline at Week 52', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '2.3', 'groupDescription': 'Proportion of subjects with ≥15 letters loss from baseline at Week 52', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set- last observation carried forward (FAS - LOCF)'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Who Have Absolute BCVA ≥73 ETDRS Letters at Each Post-baseline Visit for the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-7.9', 'ciUpperLimit': '8.6', 'groupDescription': 'Week 4', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 4'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.1', 'ciLowerLimit': '-14.3', 'ciUpperLimit': '2.9', 'groupDescription': 'Week 6', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 6'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciPctValue': '95', 'paramValue': '-4.0', 'ciLowerLimit': '-13.3', 'ciUpperLimit': '4.4', 'groupDescription': 'Week 8', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 8'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.0', 'ciLowerLimit': '-16.4', 'ciUpperLimit': '2.3', 'groupDescription': 'Week 12', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 12'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.8', 'ciLowerLimit': '-19.2', 'ciUpperLimit': '-0.0', 'groupDescription': 'Week 16', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 16'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.8', 'ciLowerLimit': '-19.0', 'ciUpperLimit': '-0.0', 'groupDescription': 'Week 18', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 18'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.7', 'ciLowerLimit': '-15.8', 'ciUpperLimit': '3.9', 'groupDescription': 'Week 20', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 20'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.4', 'ciLowerLimit': '-23.9', 'ciUpperLimit': '-3.1', 'groupDescription': 'Week 24', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 24'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.4', 'ciLowerLimit': '-22.0', 'ciUpperLimit': '-2.1', 'groupDescription': 'Week 28', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 28'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.4', 'ciLowerLimit': '-26.0', 'ciUpperLimit': '-4.8', 'groupDescription': 'Week 32', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 32'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.8', 'ciLowerLimit': '-29.5', 'ciUpperLimit': '-8.9', 'groupDescription': 'Week 36', 'statisticalMethod': 'Clopper-Pearson exact method.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 36'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.4', 'ciLowerLimit': '-28.7', 'ciUpperLimit': '-8.6', 'groupDescription': 'Week 40', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 40'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.9', 'ciLowerLimit': '-25.6', 'ciUpperLimit': '-4.4', 'groupDescription': 'Week 44', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 44'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.3', 'ciLowerLimit': '-23.6', 'ciUpperLimit': '-3.4', 'groupDescription': 'Week 48', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 48'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.6', 'ciLowerLimit': '-23.5', 'ciUpperLimit': '-2.9', 'groupDescription': 'Week 52', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 52'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - LOCF'}, {'type': 'SECONDARY', 'title': 'Number (%) of Subjects With q8w Treatment Need as Assessed by the Investigator at First Disease Activity Assessment (DAA) Visit - Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-13.6', 'ciUpperLimit': '11.2', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 32', 'description': 'To evaluate the efficacy related to dosing regimen of brolucizumab', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - Observed (Patients with a valid observed value for the outcome measure.)'}, {'type': 'SECONDARY', 'title': 'Number (%) of Subjects With q8w Treatment Need as Assessed by the Investigator at Week 36, and Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 36 (n=105,113)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 (n=102,104)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 36, Week 48', 'description': 'To evaluate the efficacy related to dosing regimen of brolucizumab', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 52 in Central Subfield Thickness (CSFT) for the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'categories': [{'measurements': [{'value': '-225.2', 'spread': '9.71', 'groupId': 'OG000'}, {'value': '-215.0', 'spread': '9.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.2', 'ciLowerLimit': '-37.3', 'ciUpperLimit': '17.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.79', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.', 'unitOfMeasure': 'micrometer', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set- last observation carried forward (FAS - LOCF)'}, {'type': 'SECONDARY', 'title': 'Average Change From Baseline Over the Period Week 40 Through Week 52 in Central Subfield Thickness (CSFT) for the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'categories': [{'measurements': [{'value': '-215.1', 'spread': '8.69', 'groupId': 'OG000'}, {'value': '-212.7', 'spread': '8.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-26.8', 'ciUpperLimit': '21.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.34', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, over the period of Week 40 to Week 52', 'description': 'Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.', 'unitOfMeasure': 'micrometer', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set- last observation carried forward (FAS - LOCF)'}, {'type': 'SECONDARY', 'title': 'Average Change From Baseline Over the Period Week 4 Through Week 52 in Central Subfield Thickness (CSFT) for the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'categories': [{'measurements': [{'value': '-207.7', 'spread': '7.77', 'groupId': 'OG000'}, {'value': '-199.2', 'spread': '7.80', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.5', 'ciLowerLimit': '-30.3', 'ciUpperLimit': '13.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.03', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, over the period of Week 4 to Week 52', 'description': 'Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.', 'unitOfMeasure': 'micrometer', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set- last observation carried forward (FAS - LOCF)'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of Patients Who Have CSFT (<280 Microns) at Each Assessment Visit for the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.3', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '13.5', 'groupDescription': 'Week 4', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.8', 'ciLowerLimit': '1.4', 'ciUpperLimit': '20.6', 'groupDescription': 'Week 6', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.1', 'ciLowerLimit': '3.9', 'ciUpperLimit': '25.3', 'groupDescription': 'Week 8', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.1', 'ciLowerLimit': '2.8', 'ciUpperLimit': '24.9', 'estimateComment': 'Proportion estimates (%) = 39.3', 'groupDescription': 'Week 12', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciPctValue': '95', 'paramValue': '16.8', 'ciLowerLimit': '5.1', 'ciUpperLimit': '28.6', 'groupDescription': 'Week 16', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.4', 'ciLowerLimit': '3.1', 'ciUpperLimit': '26.6', 'groupDescription': 'Week 18', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.7', 'ciLowerLimit': '3.5', 'ciUpperLimit': '27.1', 'groupDescription': 'Week 20', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.1', 'ciLowerLimit': '7.2', 'ciUpperLimit': '30.2', 'groupDescription': 'Week 24', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.4', 'ciLowerLimit': '4.9', 'ciUpperLimit': '27.9', 'groupDescription': 'Week 28', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.1', 'ciLowerLimit': '0.4', 'ciUpperLimit': '24.4', 'groupDescription': 'Week 32', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.0', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '18.0', 'groupDescription': 'Week 36', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.2', 'ciLowerLimit': '3.3', 'ciUpperLimit': '26.1', 'groupDescription': 'Week 40', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.2', 'ciLowerLimit': '1.9', 'ciUpperLimit': '25.7', 'groupDescription': 'Week 44', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.9', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '23.6', 'groupDescription': 'Week 48', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.9', 'ciLowerLimit': '5.8', 'ciUpperLimit': '30.5', 'groupDescription': 'Week 52', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 52', 'description': 'Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - LOCF'}, {'type': 'SECONDARY', 'title': 'Number (%) of Patients With Progression to Proliferative Diabetic Retinopathy (PDR) as Assessed by ETDRS DRSS of at Least 61 by Week 52 for the Study Eye Among the Subset of Non-PDR Subjects at Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.8', 'ciUpperLimit': '3.6', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 52', 'description': 'As evaluated using the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye.\n\nWhen the ETDRS-DR severities were evaluable, they were converted and categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - LOCF. Subset of non-Proliferative diabetic retinopathy (PDR) subjects at screening'}, {'type': 'SECONDARY', 'title': 'Number (%) of Patients With Presence of Leakage in the Study Eye on Fluorescein Angiography (FA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.3', 'ciLowerLimit': '-13.2', 'ciUpperLimit': '4.6', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 52', 'description': 'Assessed by angiography.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - LOCF'}, {'type': 'SECONDARY', 'title': 'Number (%) of Patients With Presence of Subretinal Fluid (SRF), Intraretinal Fluid (IRF) in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-10.5', 'ciUpperLimit': '12.4', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 52', 'description': 'To evaluate the efficacy of brolucizumab relative to aflibercept over the time period by assessing changes in anatomical parameters', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set- last observation carried forward (FAS - LOCF)'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Presence of Subretinal Fluid (SRF) in the Study at Each Assessment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'Subretinal Fluid (SRF) status in the central subfield: proportion of subjects with presence of SRF in the study eye by visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - LOCF'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Presence of Intraretinal Fluid (IRF) in the Study at Each Assessment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of IRF in the study eye by visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - LOCF'}, {'type': 'SECONDARY', 'title': 'Intraretinal Fluid (IRF) Status in the Central Subfield: Proportion of Subjects With Presence of IRF in the Study Eye by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of SRF and/or IRF in the study eye by visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - LOCF'}, {'type': 'SECONDARY', 'title': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - LOCF. For subjects with an assessment of the criterion.'}, {'type': 'SECONDARY', 'title': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28', 'categories': [{'measurements': [{'value': '33.9', 'groupId': 'OG000'}, {'value': '36.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}, {'value': '49.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-13.9', 'ciUpperLimit': '8.8', 'groupDescription': 'Week 28', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 28'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-14.1', 'ciUpperLimit': '9.0', 'groupDescription': 'Week 52', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 52'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.', 'unitOfMeasure': 'Percentage estimates', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - LOCF. For subjects with an assessment of the criterion.'}, {'type': 'SECONDARY', 'title': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - LOCF. For subjects with an assessment of the criterion.'}, {'type': 'SECONDARY', 'title': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28', 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}, {'value': '11.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '19.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '12.6', 'groupDescription': 'Week 28', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 28'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-10.5', 'ciUpperLimit': '9.3', 'groupDescription': 'Week 52', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 52'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.', 'unitOfMeasure': 'Percentage estimates', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - LOCF. For subjects with an assessment of the criterion.'}, {'type': 'SECONDARY', 'title': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Worsening From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - LOCF. For subjects with an assessment of the criterion.'}, {'type': 'SECONDARY', 'title': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Worsening From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.7', 'ciUpperLimit': '2.9', 'groupDescription': 'Week 28', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 28'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.', 'unitOfMeasure': 'Percentage estimates', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - LOCF. For subjects with an assessment of the criterion.'}, {'type': 'SECONDARY', 'title': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Worsening From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - LOCF. For subjects with an assessment of the criterion.'}, {'type': 'SECONDARY', 'title': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Worsening From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.7', 'ciUpperLimit': '2.9', 'groupDescription': 'Week 28', 'statisticalMethod': 'Clopper-Pearson exact method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive, Week 28'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.', 'unitOfMeasure': 'Percentage estimates', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - LOCF. For subjects with an assessment of the criterion.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Overall Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '11.97', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '15.98', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=101,101)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '13.87', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '16.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '2.3', 'groupDescription': 'Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '3.3', 'groupDescription': 'Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - General Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28 (n=96,103)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.4', 'spread': '18.80', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '18.75', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=101,101)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.9', 'spread': '18.23', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '17.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Ocular Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28 (n=96,103)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '20.16', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '24.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=101,101)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '22.51', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '25.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Near Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28 (n=96,103)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '20.79', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '24.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=100,101)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '22.12', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '25.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Distance Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28 (n=96,103)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '17.54', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '22.34', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=101,101)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '18.42', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '22.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28 (n=96,103)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '14.86', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '18.98', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=101,101)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '15.47', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '17.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28 (n=96,103)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '23.94', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '26.85', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=101,101)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '27.94', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '27.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Dependency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28 (n=96,103)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '27.90', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '29.86', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=101,101)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '30.77', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '33.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Driving', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28 (n=22,22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '11.69', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '23.09', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=28,21)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '10.91', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '23.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Color Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28 (n=94,100)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '17.22', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '19.87', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=96,92)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '17.27', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '17.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Peripheral Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28 (n=96,103)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '14.20', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '20.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=101,101)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '19.69', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '19.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - General Health Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Week 28 (n=96,103)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '26.47', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '26.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=101,101)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '26.24', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '26.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - Observed'}, {'type': 'SECONDARY', 'title': 'Brolucizumab Serum Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.1', 'spread': '4.40', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 + 1 Day (n=7,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.4', 'spread': '4.81', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Approximately 24 hours post Day 1 treatment and approximately 24 hours post Week 24 treatment', 'description': 'To confirm the systemic brolucizumab exposure in a subset of patients.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set. Patients in the Safety set with a valid value for the outcome measure.\n\nAnalysis for Weeks 4, 12, 24, 36 and 52 were below the level of quantification (BLQ).'}, {'type': 'SECONDARY', 'title': 'Number (%) of Patients Who Have Positive Anti-drug Antibody (ADA) Status in Brolucizumab Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'ADA negative (ADA Negative or titer value of 40 at pre-dose) (n=64,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'ADA positive with no boost (ADA Positive at pre-dose) (n=85,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Induced (ADA Negative at pre-dose) (n=46,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Boosted (ADA Positive at pre-dose) (n=85,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 52', 'description': 'To assess the immunogenicity of brolucizumab', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set. Patients in the Safety set with a valid value for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'Number of subjects with at least one AE', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Visual acuity reduced', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Intraocular pressure increased', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Meibomian gland dysfunction', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Cataract', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctival haemorrhage', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Vitreous opacities', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dry eye', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Epiretinal membrane', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Eye pruritus', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Uveitis', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vitreous haemorrhage', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Xerophthalmia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events are reported from first dose of study treatment until end of study treatment plus 30days post treatment, up to a maximum duration of approximately 52 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Non-ocular Adverse Events (AEs) (>=2% in Any Treatment Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events are reported from first dose of study treatment until end of study treatment plus 30days post treatment, up to a maximum duration of approximately 52 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'POST_HOC', 'title': 'All Collected Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'classes': [{'title': 'On-Treatment Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'All Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On-treatment - up to 52 weeks; Post-treatment - greater than 30 days after last treatment, until study completion, up to Week 52', 'description': 'On-treatment deaths are reported from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to a maximum timeframe of approximately 52 weeks. Post-treatment deaths are reported for the timeframe of greater than 30 days after last treatment, until study completion, up to Week 52. All deaths refer to the sum of on-treatment and post-treatment deaths.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'FG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '131'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance'}, {'id': 'BG001', 'title': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '9.20', 'groupId': 'BG000'}, {'value': '58.7', 'spread': '9.92', 'groupId': 'BG001'}, {'value': '59.6', 'spread': '9.59', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-08', 'size': 664217, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-01T11:25', 'hasProtocol': True}, {'date': '2023-02-16', 'size': 591659, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-01T11:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 266}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2019-08-14', 'resultsFirstSubmitDate': '2023-11-01', 'studyFirstSubmitQcDate': '2019-08-14', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-15', 'studyFirstPostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline at Week 52 in Best-corrected Visual Acuity (BCVA) for the Study Eye.', 'timeFrame': 'Baseline to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.'}, {'measure': 'Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 40 Through Week 52 for the Study Eye', 'timeFrame': 'Week 40 to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline by Visit up to Week 52 in Best-corrected Visual Acuity (BCVA) for the Study Eye', 'timeFrame': 'Baseline, Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.'}, {'measure': 'Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 4 Through Week 52 for the Study Eye', 'timeFrame': 'Week 4 to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.'}, {'measure': 'Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 20 Through Week 52 for the Study Eye', 'timeFrame': 'Week 20 to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.'}, {'measure': 'Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 28 Through Week 52 for the Study Eye', 'timeFrame': 'Week 28 to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.'}, {'measure': 'Time-to-first q8w Treatment Need: Summary for Brolucizumab Subjects by Disease Activity Assessment Visit', 'timeFrame': 'Baseline (Week 0), Week 32, Week 36 and Week 48', 'description': "The estimate for the proportion of subjects with a positive q12w treatment status was derived from Kaplan Meier time-to-event analyses for the event 'first q8w-need', applying a 'q8w-need' allocation in case of missing or confounded data attributable to lack of efficacy and/or lack of safety. As a result, the probability that subjects in brolucizumab arm do not need a q8w treatment (and therefore are maintained on a q12w treatment) up to the visit is reported in the table."}, {'measure': 'Time-to-first q8w Treatment Need: Summary for Brolucizumab Subjects by Disease Activity Assessment Visit, Within Those Subjects With no q8w-need During the Initial q12w Cycle', 'timeFrame': 'Week 36 and Week 48', 'description': "The estimate for the proportion of subjects with a positive q12w treatment status was derived from Kaplan Meier time-to-event analyses for the event 'first q8w-need', applying a 'q8w-need' allocation in case of missing or confounded data attributable to lack of efficacy and/or lack of safety. As a result, the probability that subjects in brolucizumab arm do not need a q8w treatment (and therefore are maintained on a q12w treatment) up to the visit is reported in the table."}, {'measure': 'Number and Percentage of Patients Who Gained in ≥5, ≥10 and ≥15 ETDRS Letters in BCVA From Baseline to Week 52 for the Study Eye', 'timeFrame': 'Baseline, Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.'}, {'measure': 'Time to Achieve Gain of >= 5 Letters in BCVA From Baseline or Reach BCVA >=84 Letters for the Study Eye - Probability of BCVA Gain', 'timeFrame': 'Baseline up to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.'}, {'measure': 'Time to Achieve Gain of >= 10 Letters in BCVA From Baseline or Reach BCVA >=84 Letters for the Study Eye - Probability of BCVA Gain', 'timeFrame': 'Baseline up to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.'}, {'measure': 'Time to Achieve Gain of >= 15 Letters in BCVA From Baseline or Reach BCVA >=84 Letters for the Study Eye - Probability of BCVA Gain', 'timeFrame': 'Baseline up to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.'}, {'measure': 'Number and Percentage of Patients Who Lost ≥5, ≥10 and ≥15 ETDRS Letters in BCVA From Baseline to Week 52 for the Study Eye', 'timeFrame': 'Baseline, Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.'}, {'measure': 'Proportion of Patients Who Have Absolute BCVA ≥73 ETDRS Letters at Each Post-baseline Visit for the Study Eye', 'timeFrame': 'Baseline up to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.'}, {'measure': 'Number (%) of Subjects With q8w Treatment Need as Assessed by the Investigator at First Disease Activity Assessment (DAA) Visit - Week 32', 'timeFrame': 'Week 32', 'description': 'To evaluate the efficacy related to dosing regimen of brolucizumab'}, {'measure': 'Number (%) of Subjects With q8w Treatment Need as Assessed by the Investigator at Week 36, and Week 48', 'timeFrame': 'Week 36, Week 48', 'description': 'To evaluate the efficacy related to dosing regimen of brolucizumab'}, {'measure': 'Change From Baseline at Week 52 in Central Subfield Thickness (CSFT) for the Study Eye', 'timeFrame': 'Baseline, Week 52', 'description': 'Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.'}, {'measure': 'Average Change From Baseline Over the Period Week 40 Through Week 52 in Central Subfield Thickness (CSFT) for the Study Eye', 'timeFrame': 'Baseline, over the period of Week 40 to Week 52', 'description': 'Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.'}, {'measure': 'Average Change From Baseline Over the Period Week 4 Through Week 52 in Central Subfield Thickness (CSFT) for the Study Eye', 'timeFrame': 'Baseline, over the period of Week 4 to Week 52', 'description': 'Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.'}, {'measure': 'Number and Percentage of Patients Who Have CSFT (<280 Microns) at Each Assessment Visit for the Study Eye', 'timeFrame': 'Baseline up to Week 52', 'description': 'Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.'}, {'measure': 'Number (%) of Patients With Progression to Proliferative Diabetic Retinopathy (PDR) as Assessed by ETDRS DRSS of at Least 61 by Week 52 for the Study Eye Among the Subset of Non-PDR Subjects at Screening', 'timeFrame': 'Baseline, Week 52', 'description': 'As evaluated using the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye.\n\nWhen the ETDRS-DR severities were evaluable, they were converted and categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.'}, {'measure': 'Number (%) of Patients With Presence of Leakage in the Study Eye on Fluorescein Angiography (FA)', 'timeFrame': 'Week 52', 'description': 'Assessed by angiography.'}, {'measure': 'Number (%) of Patients With Presence of Subretinal Fluid (SRF), Intraretinal Fluid (IRF) in the Study Eye', 'timeFrame': 'Baseline up to Week 52', 'description': 'To evaluate the efficacy of brolucizumab relative to aflibercept over the time period by assessing changes in anatomical parameters'}, {'measure': 'Number of Patients With Presence of Subretinal Fluid (SRF) in the Study at Each Assessment Visit', 'timeFrame': 'Week 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'Subretinal Fluid (SRF) status in the central subfield: proportion of subjects with presence of SRF in the study eye by visit'}, {'measure': 'Number of Patients With Presence of Intraretinal Fluid (IRF) in the Study at Each Assessment Visit', 'timeFrame': 'Week 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of IRF in the study eye by visit'}, {'measure': 'Intraretinal Fluid (IRF) Status in the Central Subfield: Proportion of Subjects With Presence of IRF in the Study Eye by Visit', 'timeFrame': 'Week 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of SRF and/or IRF in the study eye by visit'}, {'measure': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.'}, {'measure': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.'}, {'measure': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.'}, {'measure': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.'}, {'measure': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Worsening From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.'}, {'measure': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Worsening From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.'}, {'measure': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Worsening From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.'}, {'measure': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Worsening From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.'}, {'measure': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Overall Score', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - General Vision', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Ocular Pain', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Near Activities', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Distance Activities', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Social Functioning', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Mental Health', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Dependency', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Driving', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Color Vision', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Peripheral Vision', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - General Health Rating', 'timeFrame': 'Baseline, Week 28 and Week 52', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Brolucizumab Serum Concentration', 'timeFrame': 'Approximately 24 hours post Day 1 treatment and approximately 24 hours post Week 24 treatment', 'description': 'To confirm the systemic brolucizumab exposure in a subset of patients.'}, {'measure': 'Number (%) of Patients Who Have Positive Anti-drug Antibody (ADA) Status in Brolucizumab Arm', 'timeFrame': 'Up to Week 52', 'description': 'To assess the immunogenicity of brolucizumab'}, {'measure': 'Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye', 'timeFrame': 'Adverse events are reported from first dose of study treatment until end of study treatment plus 30days post treatment, up to a maximum duration of approximately 52 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject'}, {'measure': 'Number of Subjects With Non-ocular Adverse Events (AEs) (>=2% in Any Treatment Arm)', 'timeFrame': 'Adverse events are reported from first dose of study treatment until end of study treatment plus 30days post treatment, up to a maximum duration of approximately 52 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic Macular edema (DME)', 'Intravitreal injection', 'brolucizumab', 'aflibercept', 'macular edema', 'diabetic retinopathy'], 'conditions': ['Diabetic Macular Edema']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1867', 'label': 'A Plain Language Trial Summary is available on www.novctrd.com'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of Chinese patients with visual impairment due to Diabetic Macular Edema.', 'detailedDescription': 'The study is a randomized, double-masked, multi-center, active-controlled, 2-arm study in Chinese patients with Diabetic macular edema (DME). Approximately 335 Chinese patients were planned to be screened (20% screening failure rate expected) and approximately 268 (134 per arm) patients were planned to be randomized in approximately 25 centers.\n\nPatients who met all the inclusion and none of the exclusion criteria were randomized in a 1:1 ratio to one of two treatment arms:\n\n* Brolucizumab 6 mg: 5 × every 6 weeks (q6w) loading then every 12 weeks (q12w) or every 8 weeks (q8w) maintenance\n* Aflibercept 2 mg: 5 × every 4 weeks (q4w) loading then q8w maintenance\n\nDisease activity assessments (DAAs) were conducted by the masked investigator for both treatment arms at Weeks 32, 36, and 48. In the brolucizumab arm, subjects who qualified for q12w during this initial q12w interval continued on a q12w treatment frequency unless disease activity was identified at the subsequent DAA visit at Week 48, in which case subjects were switched to a q8w treatment interval until Week 52.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed informed consent must be obtained prior to participation in the study.\n2. Patients ≥18 years of age at screening\n3. Patients with type 1 or type 2 diabetes mellitus (DM) and Hemoglobin A1c (HbA1c) of ≤10% at screening\n4. Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain as stable as medically acceptable during the course of the study\n5. Study Eye Visual impairment due to diabetic macular edema (DME) with:\n\n * Best-corrected visual acuity (BCVA) score between 78 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) testing charts at a starting testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/320) at screening and baseline\n * DME involving the center of the macula, with central subfield retinal thickness (e.g. measured from retinal pigment epithelium (RPE) to the inner limiting membrane (ILM) inclusively) of ≥320 μm on Spectral domain optical coherence tomography (SD-OCT) at screening.\n\nExclusion Criteria:\n\n* Active Proliferative diabetic retinopathy (PDR) in the study eye as per investigator\n* Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention for the duration of the study (e.g. cataract, vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization (CNV) of any cause)\n* Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline\n* Structural damage of the fovea in the study eye at screening likely to preclude improvement in visual acuity following the resolution of macular edema (ME), including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques\n* Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \\> 25 mmHg on medication or according to investigator's judgment at Screening or Baseline\n* Neovascularization of the iris in the study eye at screening or baseline\n* Evidence of vitreomacular traction in the study eye at screening or baseline which in the opinion of the investigator, affects visual acuity\n* Previous treatment with any anti-vascular growth factor (VEGF) drug or investigational drugs in the study eye"}, 'identificationModule': {'nctId': 'NCT04058067', 'acronym': 'KINGLET', 'briefTitle': 'To Compare Brolucizumab to Aflibercept in Chinese Patients With Visual Impairment Due to Diabetic Macular Edema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A One-Year, Randomized, Double-Masked, Multicenter, Phase III, Two-Arm Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Chinese Patients With Visual Impairment Due to Diabetic Macular Edema', 'orgStudyIdInfo': {'id': 'CRTH258B2304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brolucizumab 6 mg', 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance', 'interventionNames': ['Drug: Brolucizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aflibercept 2 mg', 'description': '5 x every 4 weeks loading then every 8 weeks maintenance', 'interventionNames': ['Drug: Aflibercept']}], 'interventions': [{'name': 'Brolucizumab', 'type': 'DRUG', 'otherNames': ['RTH258'], 'description': '5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance', 'armGroupLabels': ['Brolucizumab 6 mg']}, {'name': 'Aflibercept', 'type': 'DRUG', 'otherNames': ['Eylea'], 'description': '5 x every 4 weeks loading then every 8 weeks maintenance', 'armGroupLabels': ['Aflibercept 2 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '515041', 'city': 'Shantou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}, {'zip': '150001', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '430070', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '214002', 'city': 'Wuxi', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'zip': '130041', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '2666000', 'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300020', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '300070', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310014', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '325027', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'zip': '100034', 'city': 'Beijing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100044', 'city': 'Beijing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100191', 'city': 'Beijing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400038', 'city': 'Chongqing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '400042', 'city': 'Chongqing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '210036', 'city': 'Nanjing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200031', 'city': 'Shanghai', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200080', 'city': 'Shanghai', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200092', 'city': 'Shanghai', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://clinicalstudydatarequest.com/', 'ipdSharing': 'YES', '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. This 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'}}}}