Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-02-18 @ 10:07 AM
Study NCT ID:
NCT02699450
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2016-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723200', 'term': 'faricimab'}, {'id': 'D000069579', 'term': 'Ranibizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline until the final study visit (up to 36 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 48, 'seriousNumAtRisk': 89, 'deathsNumAffected': 2, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 31, 'seriousNumAtRisk': 55, 'deathsNumAffected': 1, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 45, 'seriousNumAtRisk': 80, 'deathsNumAffected': 2, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Diabetic retinal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Retinal exudates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Cataract subcapsular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Red blood cell sedimentation rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Fracture displacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Neuropathic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Central nervous system lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hemiplegic migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in BCVA Letter Score at Week 24, in Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '11.9'}, {'value': '11.7', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '13.3'}, {'value': '13.9', 'groupId': 'OG002', 'lowerLimit': '12.2', 'upperLimit': '15.6'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.4', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '3.4', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm B minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Mixed Effects Model of Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.'}, {'pValue': '0.03', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '3.6', 'ciLowerLimit': '1.5', 'ciUpperLimit': '5.6', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Mixed Effects Model of Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The primary analysis used a Linear Mixed Effects Model for Repeated Measurements. Missing values were not imputed; it was assumed that the data were missing at random.", 'unitOfMeasure': 'BCVA letters', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all treatment-naive participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in BCVA Letter Score at Week 24, in Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '10.8'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '12.3'}]}]}], 'analyses': [{'pValue': '0.63', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.3', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '5.0', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Mixed Effects Model of Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The primary analysis used a Linear Mixed Effects Model for Repeated Measurements. Missing values were not imputed; it was assumed that the data were missing at random.", 'unitOfMeasure': 'BCVA letters', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all previously treated participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in BCVA Letter Score at Week 24, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '10.7'}, {'value': '11.7', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '13.4'}, {'value': '12.3', 'groupId': 'OG002', 'lowerLimit': '10.9', 'upperLimit': '13.7'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '2.3', 'ciLowerLimit': '0.2', 'ciUpperLimit': '4.3', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm B minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Mixed Effects Model of Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.'}, {'pValue': '0.04', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '2.9', 'ciLowerLimit': '1.1', 'ciUpperLimit': '4.7', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Mixed Effects Model of Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The primary analysis used a Linear Mixed Effects Model for Repeated Measurements. Missing values were not imputed; it was assumed that the data were missing at random.", 'unitOfMeasure': 'BCVA letters', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'groupId': 'OG000', 'lowerLimit': '27.3', 'upperLimit': '44.1'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '27.9', 'upperLimit': '45.0'}, {'value': '42.5', 'groupId': 'OG002', 'lowerLimit': '33.5', 'upperLimit': '52.1'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.8', 'ciLowerLimit': '-11.3', 'ciUpperLimit': '12.8', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm B minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Generalized Estimating Equations Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, visit, and visit by treatment group interaction term.'}, {'pValue': '0.46', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '7.3', 'ciLowerLimit': '-5.4', 'ciUpperLimit': '19.9', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Generalized Estimating Equations Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, visit, and visit by treatment group interaction term.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all treatment-naive participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '27.8'}, {'value': '23.2', 'groupId': 'OG001', 'lowerLimit': '14.1', 'upperLimit': '35.7'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '6.4', 'ciLowerLimit': '-7.7', 'ciUpperLimit': '20.5', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Generalized Estimating Equations Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, visit, and visit by treatment group interaction term.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline up to Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all previously treated participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000', 'lowerLimit': '22.7', 'upperLimit': '35.5'}, {'value': '35.3', 'groupId': 'OG001', 'lowerLimit': '27.4', 'upperLimit': '44.2'}, {'value': '35.9', 'groupId': 'OG002', 'lowerLimit': '28.9', 'upperLimit': '43.6'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '6.6', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '17.2', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm B minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Generalized Estimating Equations Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, visit, and visit by treatment group interaction term.'}, {'pValue': '0.34', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '7.2', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '17.0', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Generalized Estimating Equations Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, visit, and visit by treatment group interaction term.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline up to Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000', 'lowerLimit': '60.2', 'upperLimit': '76.7'}, {'value': '78.5', 'groupId': 'OG001', 'lowerLimit': '70.3', 'upperLimit': '84.9'}, {'value': '75.8', 'groupId': 'OG002', 'lowerLimit': '66.8', 'upperLimit': '83.0'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '9.5', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '20.6', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm B minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Generalized Estimating Equations Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, visit, and visit by treatment group interaction term.'}, {'pValue': '0.45', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '6.8', 'ciLowerLimit': '-4.9', 'ciUpperLimit': '18.5', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Generalized Estimating Equations Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, visit, and visit by treatment group interaction term.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all treatment-naive participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000', 'lowerLimit': '57.3', 'upperLimit': '78.7'}, {'value': '68.4', 'groupId': 'OG001', 'lowerLimit': '55.4', 'upperLimit': '79.0'}]}]}], 'analyses': [{'pValue': '0.96', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.6', 'ciLowerLimit': '-16.8', 'ciUpperLimit': '15.5', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Generalized Estimating Equations Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, visit, and visit by treatment group interaction term.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all previously treated participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000', 'lowerLimit': '62.1', 'upperLimit': '75.2'}, {'value': '78.9', 'groupId': 'OG001', 'lowerLimit': '70.8', 'upperLimit': '85.2'}, {'value': '73.2', 'groupId': 'OG002', 'lowerLimit': '65.9', 'upperLimit': '79.4'}]}]}], 'analyses': [{'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '9.9', 'ciLowerLimit': '0.1', 'ciUpperLimit': '19.7', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm B minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Generalized Estimating Equations Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, visit, and visit by treatment group interaction term.'}, {'pValue': '0.57', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '4.2', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '13.6', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Generalized Estimating Equations Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, visit, and visit by treatment group interaction term.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '18.7'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '15.3'}, {'value': '9.8', 'groupId': 'OG002', 'lowerLimit': '5.5', 'upperLimit': '16.8'}]}]}], 'analyses': [{'pValue': '0.64', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.8', 'ciLowerLimit': '-10.5', 'ciUpperLimit': '4.9', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm B minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Generalized Estimating Equations Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, visit, and visit by treatment group interaction term.'}, {'pValue': '0.78', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.8', 'ciLowerLimit': '-9.8', 'ciUpperLimit': '6.2', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Generalized Estimating Equations Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, visit, and visit by treatment group interaction term.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all treatment-naive participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '20.6'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '19.1'}]}]}], 'analyses': [{'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.3', 'ciLowerLimit': '-12.7', 'ciUpperLimit': '8.2', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Generalized Estimating Equations Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, visit, and visit by treatment group interaction term.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all previously treated participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '16.6'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '17.5'}, {'value': '9.1', 'groupId': 'OG002', 'lowerLimit': '5.6', 'upperLimit': '14.6'}]}]}], 'analyses': [{'pValue': '0.93', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.5', 'ciLowerLimit': '-7.7', 'ciUpperLimit': '6.7', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm B minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Generalized Estimating Equations Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, visit, and visit by treatment group interaction term.'}, {'pValue': '0.69', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.0', 'ciLowerLimit': '-8.3', 'ciUpperLimit': '4.4', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Generalized Estimating Equations Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, visit, and visit by treatment group interaction term.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Foveal Center Point Thickness at Week 24, in Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-243.4', 'groupId': 'OG000', 'lowerLimit': '-261.2', 'upperLimit': '-225.2'}, {'value': '-249.9', 'groupId': 'OG001', 'lowerLimit': '-269.5', 'upperLimit': '-230.4'}, {'value': '-266.2', 'groupId': 'OG002', 'lowerLimit': '-286.6', 'upperLimit': '-245.8'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-6.5', 'ciLowerLimit': '-27.8', 'ciUpperLimit': '14.7', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm B minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Mixed Effects Model of Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.'}, {'pValue': '0.18', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-22.8', 'ciLowerLimit': '-44.5', 'ciUpperLimit': '-1.2', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Mixed Effects Model of Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Foveal center point thickness (FCPT) is defined as the thickness from the inner limiting membrane to the retinal pigment epithelial at the horizontal slice closest to the center of the fovea. Foveal center point thickness was measured using spectral domain optical coherence tomography (SD-OCT).', 'unitOfMeasure': 'micrometers', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all treatment-naive participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Foveal Center Point Thickness at Week 24, in Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-162.1', 'groupId': 'OG000', 'lowerLimit': '-186.9', 'upperLimit': '-137.3'}, {'value': '-211.3', 'groupId': 'OG001', 'lowerLimit': '-237.1', 'upperLimit': '-185.5'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-49.2', 'ciLowerLimit': '-84.2', 'ciUpperLimit': '-14.2', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Mixed Effects Model of Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Foveal center point thickness (FCPT) is defined as the thickness from the inner limiting membrane to the retinal pigment epithelial at the horizontal slice closest to the center of the fovea. Foveal center point thickness was measured using spectral domain optical coherence tomography (SD-OCT).', 'unitOfMeasure': 'micrometers', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all previously treated participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Foveal Center Point Thickness at Week 24, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-210.7', 'groupId': 'OG000', 'lowerLimit': '-225.0', 'upperLimit': '-196.4'}, {'value': '-228.0', 'groupId': 'OG001', 'lowerLimit': '-246.4', 'upperLimit': '-209.7'}, {'value': '-239.9', 'groupId': 'OG002', 'lowerLimit': '-255.2', 'upperLimit': '-224.6'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-17.3', 'ciLowerLimit': '-38.0', 'ciUpperLimit': '3.4', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm B minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Mixed Effects Model of Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.'}, {'pValue': '0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-29.2', 'ciLowerLimit': '-47.8', 'ciUpperLimit': '-10.6', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Mixed Effects Model of Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Foveal center point thickness (FCPT) is defined as the thickness from the inner limiting membrane to the retinal pigment epithelial at the horizontal slice closest to the center of the fovea. Foveal center point thickness was measured using spectral domain optical coherence tomography (SD-OCT).', 'unitOfMeasure': 'micrometers', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Central Subfield Thickness at Week 24, in Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-204.7', 'groupId': 'OG000', 'lowerLimit': '-219.6', 'upperLimit': '-189.8'}, {'value': '-217.1', 'groupId': 'OG001', 'lowerLimit': '-233.0', 'upperLimit': '-201.2'}, {'value': '-225.8', 'groupId': 'OG002', 'lowerLimit': '-242.5', 'upperLimit': '-209.1'}]}]}], 'analyses': [{'pValue': '0.36', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-12.4', 'ciLowerLimit': '-29.7', 'ciUpperLimit': '5.0', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm B minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Mixed Effects Model of Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.'}, {'pValue': '0.13', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-21.1', 'ciLowerLimit': '-38.7', 'ciUpperLimit': '-3.5', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Mixed Effects Model of Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Central subfield thickness (CST) is defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield. Central subfield thickness was measured using SD-OCT.', 'unitOfMeasure': 'micrometers', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all treatment-naive participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Central Subfield Thickness at Week 24, in Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-148.0', 'groupId': 'OG000', 'lowerLimit': '-167.7', 'upperLimit': '-128.4'}, {'value': '-186.6', 'groupId': 'OG001', 'lowerLimit': '-206.9', 'upperLimit': '-166.4'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-38.6', 'ciLowerLimit': '-65.9', 'ciUpperLimit': '-11.3', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Mixed Effects Model of Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Central subfield thickness (CST) is defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield. Central subfield thickness was measured using SD-OCT.', 'unitOfMeasure': 'micrometers', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all previously treated participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Central Subfield Thickness at Week 24, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-180.2', 'groupId': 'OG000', 'lowerLimit': '-191.6', 'upperLimit': '-168.8'}, {'value': '-200.3', 'groupId': 'OG001', 'lowerLimit': '-214.8', 'upperLimit': '-185.8'}, {'value': '-206.9', 'groupId': 'OG002', 'lowerLimit': '-219.0', 'upperLimit': '-194.8'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-20.1', 'ciLowerLimit': '-36.4', 'ciUpperLimit': '-3.8', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm B minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Mixed Effects Model of Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-26.7', 'ciLowerLimit': '-41.3', 'ciUpperLimit': '-12.0', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The mean difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Mixed Effects Model of Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Central subfield thickness (CST) is defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield. Central subfield thickness was measured using SD-OCT.', 'unitOfMeasure': 'micrometers', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Presence of Subretinal Fluid in the Study Eye at Week 24, in Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.08', 'groupId': 'OG000', 'lowerLimit': '0.46', 'upperLimit': '7.70'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}], 'analyses': [{'pValue': '0.4948', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.08', 'ciLowerLimit': '-7.70', 'ciUpperLimit': '-0.46', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The difference between arms was calculated as Arm B minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4960', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.08', 'ciLowerLimit': '-7.70', 'ciUpperLimit': '-0.46', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Subretinal fluid is defined as the presence of fluid between the retina and the retinal pigment epithelium. Resolution of subretinal fluid was measured using SD-OCT.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all treatment-naive participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Presence of Subretinal Fluid in the Study Eye at Week 24, in Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.14', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '13.38'}, {'value': '4.35', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '9.80'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.80', 'ciLowerLimit': '-11.08', 'ciUpperLimit': '5.49', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Subretinal fluid is defined as the presence of fluid between the retina and the retinal pigment epithelium. Resolution of subretinal fluid was measured using SD-OCT.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all previously treated participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Presence of Intraretinal Fluid in the Study Eye at Week 24, in Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.76', 'groupId': 'OG000', 'lowerLimit': '81.75', 'upperLimit': '93.76'}, {'value': '81.63', 'groupId': 'OG001', 'lowerLimit': '74.54', 'upperLimit': '88.72'}, {'value': '90.91', 'groupId': 'OG002', 'lowerLimit': '85.35', 'upperLimit': '96.46'}]}]}], 'analyses': [{'pValue': '0.5759', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-6.12', 'ciLowerLimit': '-15.41', 'ciUpperLimit': '3.17', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The difference between arms was calculated as Arm B minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7437', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '3.15', 'ciLowerLimit': '-5.02', 'ciUpperLimit': '11.33', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Intraretinal fluid is described as the presence of fluid within the retina. Resolution of intraretinal fluid was measured by SD-OCT.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all treatment-naive participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Presence of Intraretinal Fluid in the Study Eye at Week 24, in Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.29', 'groupId': 'OG000', 'lowerLimit': '81.79', 'upperLimit': '96.78'}, {'value': '91.30', 'groupId': 'OG001', 'lowerLimit': '83.77', 'upperLimit': '98.83'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '2.02', 'ciLowerLimit': '-8.60', 'ciUpperLimit': '12.64', 'pValueComment': 'There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.', 'estimateComment': 'The difference between arms was calculated as Arm C minus Arm A.', 'groupDescription': 'Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Intraretinal fluid is described as the presence of fluid within the retina. Resolution of intraretinal fluid was measured by SD-OCT.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all previously treated participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Presence or Absence of Leakage at the Macula at Week 24, in Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Leakage Present', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Leakage Absent', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Leakage at the macula describes the leakage of fluorescein at the macula region as measured by fundus fluorescein angiography (FFA).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all treatment-naive participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Week 24.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Presence or Absence of Leakage at the Macula at Week 24, in Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Leakage Present', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Leakage Absent', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Leakage at the macula describes the leakage of fluorescein at the macula region as measured by fundus fluorescein angiography (FFA).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: all previously treated participants who had received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study). This analysis only included participants with non-missing assessments at Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Size of the Foveal Avascular Zone at Week 24, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'timeFrame': 'Baseline, Week 24', 'description': 'The size of the foveal avascular zone was to be measured by fundus fluorescein angiography (FFA).', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the poor image quality available, size of the foveal avascular zone could not be assessed in any of the participant populations.'}, {'type': 'SECONDARY', 'title': 'Mean Plasma Concentrations of Ranibizumab (Arm A) or Faricimab (Arms B and C) Over Time, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.20', 'spread': '7.84', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.52', 'spread': '7.57', 'groupId': 'OG000'}, {'value': '48.36', 'spread': '22.46', 'groupId': 'OG001'}, {'value': '172.24', 'spread': '80.59', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.86', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '6.97', 'spread': '4.96', 'groupId': 'OG001'}, {'value': '20.60', 'spread': '13.46', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '9.32', 'spread': '5.93', 'groupId': 'OG001'}, {'value': '22.38', 'spread': '13.63', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '7.11', 'spread': '4.64', 'groupId': 'OG001'}, {'value': '22.59', 'spread': '18.10', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '8.69', 'spread': '5.06', 'groupId': 'OG001'}, {'value': '20.18', 'spread': '16.37', 'groupId': 'OG002'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '3.80', 'spread': '3.28', 'groupId': 'OG001'}, {'value': '8.18', 'spread': '6.98', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '2.42', 'groupId': 'OG001'}, {'value': '2.94', 'spread': '3.07', 'groupId': 'OG002'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '0.82', 'spread': '0.97', 'groupId': 'OG002'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.00', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose at Baseline and Weeks 1, 4, 12, 20, 24, 26, 28, 32, and 36', 'description': 'Plasma concentrations of ranibizumab were measured by an appropriate assay only from samples of participants randomized to Arm A: 0.3 mg Ranibizumab. Plasma concentrations of faricimab were measured by a specific validated enzyme-linked immunoabsorbent assay (ELISA) only from samples of participants randomized to Arm B: 1.5 mg Faricimab and Arm C: 6 mg Faricimab. Baseline was defined as the last non-missing predose assessment. The lower limit of quantification (LLOQ) for the ranibizumab and faricimab assays were 0.015 nanograms per millilitre (ng/mL) and 0.800 ng/mL, respectively. Values below the limit of quantification were imputed as LLOQ divided by 2.', 'unitOfMeasure': 'nanograms per millilitre (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics Population: The analysis included participants who received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study) and had plasma samples available at a given study visit timepoint.'}, {'type': 'SECONDARY', 'title': 'Baseline and Change From Baseline in Free Vascular Endothelial Growth Factor (VEGF) Plasma Levels Over Time, in Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Baseline (BL) - Value at Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.93', 'spread': '52.75', 'groupId': 'OG000'}, {'value': '14.93', 'spread': '19.70', 'groupId': 'OG001'}, {'value': '12.45', 'spread': '7.62', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-9.44', 'spread': '49.77', 'groupId': 'OG000'}, {'value': '-3.85', 'spread': '20.99', 'groupId': 'OG001'}, {'value': '-3.61', 'spread': '6.96', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.68', 'spread': '21.20', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '21.76', 'groupId': 'OG001'}, {'value': '-0.49', 'spread': '9.31', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.54', 'spread': '22.50', 'groupId': 'OG000'}, {'value': '-1.61', 'spread': '20.82', 'groupId': 'OG001'}, {'value': '1.67', 'spread': '16.69', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Change from BL at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.31', 'spread': '23.97', 'groupId': 'OG000'}, {'value': '2.92', 'spread': '18.23', 'groupId': 'OG001'}, {'value': '2.83', 'spread': '13.74', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.37', 'spread': '13.09', 'groupId': 'OG000'}, {'value': '-2.98', 'spread': '6.27', 'groupId': 'OG001'}, {'value': '-2.43', 'spread': '7.08', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '5.87', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '12.17', 'groupId': 'OG001'}, {'value': '7.15', 'spread': '7.73', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.30', 'spread': '8.13', 'groupId': 'OG000'}, {'value': '-35.85', 'spread': '65.08', 'groupId': 'OG001'}, {'value': '4.50', 'spread': '5.97', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.75', 'spread': '14.00', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '7.71', 'groupId': 'OG001'}, {'value': '2.07', 'spread': '10.38', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36', 'description': 'The concentration of free VEGF was determined in plasma samples using an enzyme-linked immunosorbent assay (ELISA) method. The lower limit of quantification (LLOQ) of the assay was 15.6 picograms per millilitre (pg/mL). Plasma free VEGF concentrations below the limit of quantification were imputed as LLOQ divided by 2.', 'unitOfMeasure': 'picograms per millilitre (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics Population: The analysis included participants who received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study) and had plasma samples available at a given study visit timepoint.'}, {'type': 'SECONDARY', 'title': 'Baseline and Change From Baseline in Free Vascular Endothelial Growth Factor (VEGF) Plasma Levels Over Time, in Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Baseline (BL) - Value at Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.94', 'spread': '10.00', 'groupId': 'OG000'}, {'value': '7.80', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '16.21', 'spread': '10.22', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '14.24', 'groupId': 'OG000'}, {'value': '8.20', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '-7.40', 'spread': '12.08', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.93', 'spread': '15.07', 'groupId': 'OG000'}, {'value': '14.50', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '-0.80', 'spread': '11.11', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.83', 'spread': '51.87', 'groupId': 'OG000'}, {'value': '39.20', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '0.78', 'spread': '16.55', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.10', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.60', 'spread': '31.50', 'groupId': 'OG000'}, {'value': '12.40', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '4.13', 'spread': '27.51', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.25', 'spread': '13.97', 'groupId': 'OG000'}, {'value': '16.65', 'spread': '42.34', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.32', 'spread': '20.30', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.13', 'spread': '11.24', 'groupId': 'OG000'}, {'value': '57.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.05', 'spread': '11.44', 'groupId': 'OG000'}, {'value': '21.50', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '3.53', 'spread': '21.58', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36', 'description': 'The concentration of free VEGF was determined in plasma samples using an enzyme-linked immunosorbent assay (ELISA) method. The lower limit of quantification (LLOQ) of the assay was 15.6 picograms per millilitre (pg/mL). Plasma free VEGF concentrations below the limit of quantification were imputed as LLOQ divided by 2.', 'unitOfMeasure': 'picograms per millilitre (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics Population: The analysis included participants who received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study) and had plasma samples available at a given study visit timepoint.'}, {'type': 'SECONDARY', 'title': 'Baseline and Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Levels Over Time, in Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Baseline (BL) - Value at Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.77', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '2.07', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '2.30', 'spread': '1.88', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.80', 'groupId': 'OG001'}, {'value': '0.75', 'spread': '0.79', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '0.24', 'spread': '0.79', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '1.02', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.08', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Change from BL at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.61', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.25', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '0.58', 'spread': '0.78', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '-0.20', 'spread': '0.49', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '1.91', 'groupId': 'OG001'}, {'value': '0.42', 'spread': '0.21', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '1.45', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.83', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36', 'description': 'Total Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.09 nanograms per millilitre (ng/mL). Plasma total Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2.', 'unitOfMeasure': 'nanograms per millilitre (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics Population: The analysis included participants who received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study) and had plasma samples available at a given study visit timepoint.'}, {'type': 'SECONDARY', 'title': 'Baseline and Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Levels Over Time, in Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Baseline (BL) - Value at Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.05', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '2.38', 'spread': '1.04', 'groupId': 'OG001'}, {'value': '2.46', 'spread': '1.37', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '1.01', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '-0.22', 'spread': '0.88', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '0.25', 'spread': '1.11', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.74', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Change from BL at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '-0.11', 'spread': '0.86', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.76', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '-0.54', 'spread': '0.60', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '1.83', 'groupId': 'OG001'}, {'value': '-0.12', 'spread': '0.28', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '0.89', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36', 'description': 'Free Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.9 nanograms per millilitre (ng/mL). Plasma free Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2.', 'unitOfMeasure': 'nanograms per millilitre (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics Population: The analysis included participants who received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study) and had plasma samples available at a given study visit timepoint.'}, {'type': 'SECONDARY', 'title': 'Baseline and Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Levels Over Time, in Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Baseline (BL) - Value at Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.40', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '1.84', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '2.31', 'spread': '1.78', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '14.24', 'groupId': 'OG000'}, {'value': '0.11', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '0.94', 'spread': '1.12', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '0.14', 'spread': '0.87', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.33', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.46', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '-0.16', 'spread': '0.46', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.42', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.74', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '0.35', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '0.49', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '0.42', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36', 'description': 'Total Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.09 nanograms per millilitre (ng/mL). Plasma total Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2.', 'unitOfMeasure': 'nanograms per millilitre (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics Population: The analysis included participants who received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study) and had plasma samples available at a given study visit timepoint.'}, {'type': 'SECONDARY', 'title': 'Baseline and Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Levels Over Time, in Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Baseline (BL) - Value at Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.67', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '2.08', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '2.35', 'spread': '1.76', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '0.87', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '-0.17', 'spread': '0.66', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '0.61', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.49', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-0.49', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '-0.29', 'spread': '0.64', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.54', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '-1.36', 'spread': '0.83', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.59', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '0.07', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Change from BL at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated using data from a single participant.', 'groupId': 'OG001'}, {'value': '-0.19', 'spread': '0.45', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36', 'description': 'Free Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.9 nanograms per millilitre (ng/mL). Plasma free Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2.', 'unitOfMeasure': 'nanograms per millilitre (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics Population: The analysis included participants who received at least one dose of study drug grouped by treatment assigned at randomization (did not differ from actual treatment during the study) and had plasma samples available at a given study visit timepoint.'}, {'type': 'SECONDARY', 'title': 'Safety Summary of the Number of Participants With at Least One Adverse Event During the Treatment Period (up to Week 24), in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'Ocular AE', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Ocular AE in the Study Eye', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Related Ocular AE in the Study Eye', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Ocular AE in Study Eye Leading to Discontinuation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Serious Ocular AE in the Study Eye', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Ocular AE in the Fellow Eye', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Systemic AE', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}, {'title': 'Related Systemic AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Serious Systemic AE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Systemic AE Leading to Discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Related AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Any Serious AE', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Any Related Serious AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AE with Fatal Outcome', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline up to Week 24', 'description': 'This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) within 28 days of the end of the treatment period (i.e., up to Week 24). AEs are categorized as any AEs, ocular AEs occurring in the study eye or fellow eye, systemic AEs, serious AEs, AEs related to treatment with study drug, AEs leading to discontinuation of treatment with study drug, and AEs with fatal outcome. Multiple occurrences of the same AE in one individual were counted only once.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who had received at least one dose of the study drug, whether prematurely withdrawn from the study or not, grouped according to the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Safety Summary of the Number of Participants With at Least One Adverse Event During the Post-Treatment Observation Period, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'Ocular AE', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Ocular AE in the Study Eye', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Related Ocular AE in the Study Eye', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Ocular AE in Study Eye Leading to Discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Serious Ocular AE in the Study Eye', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Ocular AE in the Fellow Eye', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Systemic AE', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Related Systemic AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Serious Systemic AE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Systemic AE Leading to Discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Related AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Serious AE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Any Related Serious AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AE with Fatal Outcome', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 24 up to Week 36', 'description': 'This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) during the post-treatment observation period (i.e., from Week 24 up to Week 36). AEs are categorized as any AEs, ocular AEs occurring in the study eye or fellow eye, systemic AEs, serious AEs, AEs related to treatment with study drug, AEs leading to discontinuation of treatment with study drug, and AEs with fatal outcome. Multiple occurrences of the same AE in one individual were counted only once.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who had received at least one dose of the study drug, whether prematurely withdrawn from the study or not, grouped according to the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye During the Treatment Period by Highest Intensity, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Study Eye - Ocular AE of Any Intensity', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Study Eye - Mild Ocluar AE', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Study Eye - Moderate Ocular AE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Study Eye - Severe Ocular AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Fellow Eye - Ocular AE of Any Intensity', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Fellow Eye - Mild Ocular AE', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Fellow Eye - Moderate Ocular AE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Fellow Eye - Severe Ocular AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline up to Week 24', 'description': 'The investigator assessed adverse event severity according to the following grading scale: Mild = Discomfort noticed, but no disruption of normal daily activity; Moderate = Discomfort sufficient to reduce or affect normal daily activity; Severe = Incapacitating with inability to work or to perform normal daily activity. Only the most severe intensity was counted for multiple occurrences of the same adverse event per participant at the preferred term level. Severity and seriousness are not synonymous; regardless of severity, some adverse events may have also met seriousness criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who had received at least one dose of the study drug, whether prematurely withdrawn from the study or not, grouped according to the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Systemic Adverse Event During the Treatment Period by Highest Intensity, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Systemic AE of Any Intensity', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}, {'title': 'Mild Systemic AE', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'Moderate Systemic AE', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Severe Systemic AE', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline up to Week 24', 'description': 'The investigator assessed adverse event severity according to the following grading scale: Mild = Discomfort noticed, but no disruption of normal daily activity; Moderate = Discomfort sufficient to reduce or affect normal daily activity; Severe = Incapacitating with inability to work or to perform normal daily activity. Only the most severe intensity was counted for multiple occurrences of the same adverse event per participant at the preferred term level. Severity and seriousness are not synonymous; regardless of severity, some adverse events may have also met seriousness criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who had received at least one dose of the study drug, whether prematurely withdrawn from the study or not, grouped according to the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Systolic Blood Pressure Over Time, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Week 1 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 1 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 28 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 28 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 32 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 32 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 36 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 36 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 26, 28, 32, and 36', 'description': 'Abnormal systolic blood pressure (supine) was defined as any value outside of the standard reference range, from \\<70 (low) to \\>180 (high) millimetres of mercury (mmHg) or a change from baseline of greater than 30 mmHg (decrease or increase). Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population; the number of participants with an abnormal vital sign (numerator) is reported among the number analyzed (denominator), which represents the number of participants without the abnormal vital sign at baseline and who were evaluable at a given assessment timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Diastolic Blood Pressure Over Time, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Week 1 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 1 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 28 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 28 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 32 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 32 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 36 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 36 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 26, 28, 32, and 36', 'description': 'Abnormal diastolic blood pressure (supine) was defined as any value outside of the standard reference range, from \\<40 (low) to \\>110 (high) millimetres of mercury (mmHg) or a change from baseline of greater than 20 mmHg (decrease or increase). Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population; the number of participants with an abnormal vital sign (numerator) is reported among the number analyzed (denominator), which represents the number of participants without the abnormal vital sign at baseline and who were evaluable at a given assessment timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Abnormal Heart Rate Over Time, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Week 1 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 1 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 28 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 28 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 32 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 32 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 36 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 36 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 26, 28, 32, and 36', 'description': 'Abnormal heart rate (supine) was defined as any value outside of the standard reference range, from \\<40 (low) to \\>100 (high) beats per minute. Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population; the number of participants with an abnormal vital sign (numerator) is reported among the number analyzed (denominator), which represents the number of participants without the abnormal vital sign at baseline and who were evaluable at a given assessment timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Body Temperature Over Time, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Week 1 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Week 1 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 28 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Week 28 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 32 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Week 32 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 36 - Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Week 36 - High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 26, 28, 32, and 36', 'description': 'Abnormal body temperature (supine) was defined as any value outside of the standard reference range, from \\<36.5 (low) to \\>37.5 (high) degrees Celsius. Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population; the number of participants with an abnormal vital sign (numerator) is reported among the number analyzed (denominator), which represents the number of participants without the abnormal vital sign at baseline and who were evaluable at a given assessment timepoint.'}, {'type': 'SECONDARY', 'title': 'Mean Heart Rate at Baseline and Week 24, as Measured by Electrocardiogram in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '71.52', 'spread': '14.47', 'groupId': 'OG000'}, {'value': '73.65', 'spread': '10.43', 'groupId': 'OG001'}, {'value': '74.12', 'spread': '12.89', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '71.12', 'spread': '12.53', 'groupId': 'OG000'}, {'value': '73.96', 'spread': '11.32', 'groupId': 'OG001'}, {'value': '75.61', 'spread': '11.46', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Triplicate 12-lead electrocardiogram (ECG), i.e., three useful ECGs without artifacts, were performed on all evaluable participants. To minimize variability, it was important that participants be in a resting position for at least 10 minutes prior to the ECG evaluation. Body position was to be consistently maintained for each ECG evaluation to prevent changes in heart rate. Environmental distractions (e.g., television, radio, conversation, mobile phones) were to be minimized before and during ECG recording. Triplicate ECGs were to be obtained within a 5-minute interval. The predefined standard reference range for heart rate measured by ECG was 40 (low) to 100 (high) beats per minute.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who had received at least one dose of the study drug, whether prematurely withdrawn from the study or not, grouped according to the actual treatment received. This analysis included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Mean PR, RR, QT, QRS, QTcB, and QTcF Intervals at Baseline and Week 24, as Measured by Electrocardiogram in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'PR Interval at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '172.57', 'spread': '28.62', 'groupId': 'OG000'}, {'value': '168.50', 'spread': '31.82', 'groupId': 'OG001'}, {'value': '170.91', 'spread': '29.06', 'groupId': 'OG002'}]}]}, {'title': 'PR Interval at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '171.95', 'spread': '30.21', 'groupId': 'OG000'}, {'value': '167.49', 'spread': '26.20', 'groupId': 'OG001'}, {'value': '172.02', 'spread': '28.81', 'groupId': 'OG002'}]}]}, {'title': 'RR Interval at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '864.44', 'spread': '160.30', 'groupId': 'OG000'}, {'value': '826.04', 'spread': '119.67', 'groupId': 'OG001'}, {'value': '828.64', 'spread': '146.42', 'groupId': 'OG002'}]}]}, {'title': 'RR Interval at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '864.34', 'spread': '154.93', 'groupId': 'OG000'}, {'value': '824.13', 'spread': '126.72', 'groupId': 'OG001'}, {'value': '806.45', 'spread': '124.82', 'groupId': 'OG002'}]}]}, {'title': 'QT Interval at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '395.40', 'spread': '40.47', 'groupId': 'OG000'}, {'value': '387.87', 'spread': '30.52', 'groupId': 'OG001'}, {'value': '386.97', 'spread': '32.65', 'groupId': 'OG002'}]}]}, {'title': 'QT Interval at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '393.96', 'spread': '36.74', 'groupId': 'OG000'}, {'value': '384.30', 'spread': '28.03', 'groupId': 'OG001'}, {'value': '381.50', 'spread': '28.10', 'groupId': 'OG002'}]}]}, {'title': 'QRS Interval at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.84', 'spread': '19.80', 'groupId': 'OG000'}, {'value': '96.06', 'spread': '16.76', 'groupId': 'OG001'}, {'value': '95.26', 'spread': '15.54', 'groupId': 'OG002'}]}]}, {'title': 'QRS Interval at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.82', 'spread': '19.90', 'groupId': 'OG000'}, {'value': '96.66', 'spread': '11.24', 'groupId': 'OG001'}, {'value': '95.40', 'spread': '17.83', 'groupId': 'OG002'}]}]}, {'title': 'QTcB Interval at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '426.98', 'spread': '24.47', 'groupId': 'OG000'}, {'value': '427.85', 'spread': '24.33', 'groupId': 'OG001'}, {'value': '426.91', 'spread': '22.84', 'groupId': 'OG002'}]}]}, {'title': 'QTcB Interval at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '425.60', 'spread': '25.55', 'groupId': 'OG000'}, {'value': '424.79', 'spread': '22.93', 'groupId': 'OG001'}, {'value': '426.31', 'spread': '23.36', 'groupId': 'OG002'}]}]}, {'title': 'QTcF Interval at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '415.60', 'spread': '25.63', 'groupId': 'OG000'}, {'value': '413.61', 'spread': '23.15', 'groupId': 'OG001'}, {'value': '412.67', 'spread': '21.17', 'groupId': 'OG002'}]}]}, {'title': 'QTcF Interval at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '414.21', 'spread': '24.75', 'groupId': 'OG000'}, {'value': '410.45', 'spread': '20.35', 'groupId': 'OG001'}, {'value': '410.42', 'spread': '20.61', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Triplicate 12-lead electrocardiogram (ECG), i.e., three useful ECGs without artifacts, were performed on all evaluable participants. To minimize variability, it was important that participants be in a resting position for at least 10 minutes prior to the ECG evaluation. Body position was to be consistently maintained for each ECG evaluation to prevent changes in heart rate. Environmental distractions (e.g., television, radio, conversation, mobile phones) were to be minimized before and during ECG recording. Triplicate ECGs were to be obtained within a 5-minute interval. Baseline was defined as the last non-missing predose assessment. The predefined standard reference ranges for the intervals measured by ECG were defined as follows (ranges are from low to high, in milliseconds \\[msec\\]): PR: 120-200 msec; RR: 600-1500 msec; QT: 200-500 msec; QRS: 40-120 msec.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who had received at least one dose of the study drug, whether prematurely withdrawn from the study or not, grouped according to the actual treatment received. This analysis included participants with non-missing assessments at Baseline and Week 24.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Marked Laboratory Abnormalities in Hematology Tests, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Eosinophils, Abs., High - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Eosinophils, Abs., High - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Eosinophils, Abs., High - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hematocrit, Low - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hematocrit, Low - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hematocrit, Low - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, Low - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, Low - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, Low - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes, Abs., Low - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes, Abs., Low - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes, Abs., Low - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Ery. Mean Corpuscular Hemo., Low - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Ery. Mean Corpuscular Hemo., Low -Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Ery. Mean Corpuscular Hemo.,Low-Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils, Total, Abs., Low - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils, Total, Abs., Low - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils, Total, Abs., Low -Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils, Total, Abs., High - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils, Total, Abs., High - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils, Total, Abs., High -Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Platelets, Low - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelets, Low - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelets, Low - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelets, High - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelets, High - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelets, High - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Red Blood Cell Count, Low - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Red Blood Cell Count, Low - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Red Blood Cell Count, Low - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'White Blood Cell Count, Low - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'White Blood Cell Count, Low - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'White Blood Cell Count, Low - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Predose at Baseline, Weeks 12 and 24, and at Early Termination and Unscheduled Visits (up to 36 weeks)', 'description': "Clinical laboratory tests for hematology parameters were performed and any marked abnormal values (High or Low) were based on Roche's predefined standard reference ranges. Marked laboratory abnormalities are presented according to COG3007 abnormality criteria: Single, Not Last = abnormality detected at a single assessment, but not at the last assessment; Last or Replicated = abnormality detected at the last assessment or replicated at one or more assessments. Not every laboratory abnormality qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. Abs. = absolute count; Ery. = erythrocyte; Hemo. = hemoglobin", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who had received at least one dose of the study drug, whether prematurely withdrawn from the study or not, grouped according to the actual treatment received. This analysis included participants with non-missing assessments.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Alkaline Phosphatase, High - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline Phosphatase, High - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline Phosphatase, High - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'SGOT/AST, High - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'SGOT/AST, High - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'SGOT/AST, High - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bicarbonate, Low - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Bicarbonate, Low - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Bicarbonate, Low - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Bicarbonate, High - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Bicarbonate, High - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bicarbonate, High - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Blood Urea Nitrogen, High - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Blood Urea Nitrogen, High - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blood Urea Nitrogen, High - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Calcium, Low - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Calcium, Low - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Calcium, Low - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Chloride, Low - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Chloride, Low - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Chloride, Low - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Cholesterol, High - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Cholesterol, High - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Cholesterol, High - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Creatine Kinase, High - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Creatine Kinase, High - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Creatine Kinase, High - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine, High - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine, High - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine, High - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Gamma Glutamyl Transferase, High-Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Gamma Glutamyl Transferase, High-Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Gamma Glutamyl Transferase,High-Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Phosphorus, Low - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Phosphorus, Low - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Phosphorus, Low - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Phosphorus, High - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Phosphorus, High - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Phosphorus, High - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, High - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, High - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, High - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Sodium, Low - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Sodium, Low - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Sodium, Low - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin, High - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin, High - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin, High - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Protein, Total, Low - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Protein, Total, Low - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Protein, Total, Low - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Predose at Baseline, Weeks 12 and 24, and at Early Termination and Unscheduled Visits (up to 36 weeks)', 'description': "Clinical laboratory tests for blood chemistry parameters were performed and any marked abnormal values (High or Low) were based on Roche's predefined standard reference ranges. Marked laboratory abnormalities are presented according to COG3007 abnormality criteria: Single, Not Last = abnormality detected at a single assessment, but not at the last assessment; Last or Replicated = abnormality detected at the last assessment or replicated at one or more assessments. Not every laboratory abnormality qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. SGOT/AST = serum glutamic oxaloacetic transaminase / aspartate aminotransferase", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who had received at least one dose of the study drug, whether prematurely withdrawn from the study or not, grouped according to the actual treatment received. This analysis included participants with non-missing assessments.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Marked Laboratory Abnormalities in Coagulation Tests, in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'INR, High - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'INR, High - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'INR, High - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'aPTT, High - Any Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'aPTT, High - Single, Not Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'aPTT, High - Last or Replicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Predose at Baseline, Weeks 12 and 24, and at Early Termination and Unscheduled Visits (up to 36 weeks)', 'description': "Clinical laboratory tests for coagulation parameters were performed and any marked abnormal values (High or Low) were based on Roche's predefined standard reference ranges. Marked laboratory abnormalities are presented according to COG3007 abnormality criteria: Single, Not Last = abnormality detected at a single assessment, but not at the last assessment; Last or Replicated = abnormality detected at the last assessment or replicated at one or more assessments. Not every laboratory abnormality qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. aPTT = activated partial thromboplastin time; INR = International Normalized Ratio (prothrombin time)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who had received at least one dose of the study drug, whether prematurely withdrawn from the study or not, grouped according to the actual treatment received. This analysis included participants with non-missing assessments.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Tested Negative or Positive for Anti-Drug Antibodies Against Faricimab Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'OG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'classes': [{'title': 'Baseline - ADA Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}]}, {'title': 'Baseline - ADA Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 1 - ADA Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}, {'title': 'Week 1 - ADA Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 - ADA Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 - ADA Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 - ADA Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 - ADA Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 - ADA Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 - ADA Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 - ADA Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 - ADA Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 - ADA Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 - ADA Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 - ADA Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 - ADA Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 28 - ADA Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Week 28 - ADA Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 32 - ADA Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Week 32 - ADA Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 36 - ADA Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Week 36 - ADA Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Weeks 1, 4, 12, 16, 20, 24, 26, 28, 32, and 36', 'description': 'The number and percentage of participants who tested negative or positive for plasma anti-drug antibodies (ADA) to faricimab at baseline and at the study visits was tabulated, except for those who were randomized to treatment with ranibizumab in Arm A.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who had received at least one dose of the study drug, whether prematurely withdrawn from the study or not, grouped according to the actual treatment received. Analysis only included participants who were randomized to treatment with faricimab in Arms B and C.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'FG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'FG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Intent-to-Treat (ITT) Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '82'}]}, {'type': 'Received at Least One Dose of Study Drug', 'comment': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'Completed up to Week 24', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'comment': 'Completed Study (per pre-specified criteria)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Met Criteria for Study Exit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 229 patients were randomized, but two participants randomized to Arm C: 6 mg Faricimab were excluded from the analysis populations due to Good Clinical Practice (GCP) non-compliance at a single site.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '227', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'BG001', 'title': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'BG002', 'title': 'Arm C: 6 mg Faricimab', 'description': 'Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '227', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '62.3', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '61.5', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '60.8', 'spread': '9.2', 'groupId': 'BG002'}, {'value': '61.6', 'spread': '8.8', 'groupId': 'BG003'}]}]}, {'title': 'Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '61.6', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '61.4', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '60.5', 'spread': '9.1', 'groupId': 'BG002'}, {'value': '61.2', 'spread': '8.8', 'groupId': 'BG003'}]}]}, {'title': 'Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '63.5', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '63.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated from data for a single participant.', 'groupId': 'BG001'}, {'value': '61.5', 'spread': '9.5', 'groupId': 'BG002'}, {'value': '62.6', 'spread': '9.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline characteristics were analyzed for all participants, treatment-naive participants, and previously treated participants.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '227', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}]}, {'title': 'Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}, {'title': 'Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics were analyzed for all participants, treatment-naive participants, and previously treated participants.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '227', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '187', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics were analyzed for all participants, treatment-naive participants, and previously treated participants.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '227', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '175', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics were analyzed for all participants, treatment-naive participants, and previously treated participants.'}, {'title': 'Anti-VEGF Treatment Experience Status (Treatment-Naive or Previously Treated)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '227', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Treatment-Naive', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}, {'title': 'Previously Treated', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Approximately 210 participants were planned to be randomized to this study, including approximately 150 treatment-naive participants (1:1:1 to Arms A, B, and C) and approximately 60 participants (1:1 to Arms A and C) who had been previously treated with IVT anti-vascular endothelial growth factor (VEGF).', 'unitOfMeasure': 'Participants'}, {'title': 'Best Corrected Visual Acuity (BCVA) ETDRS Letter Score in the Study Eye at Baseline', 'classes': [{'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '224', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '61.51', 'spread': '10.43', 'groupId': 'BG000'}, {'value': '61.16', 'spread': '11.12', 'groupId': 'BG001'}, {'value': '59.48', 'spread': '12.49', 'groupId': 'BG002'}, {'value': '60.70', 'spread': '11.36', 'groupId': 'BG003'}]}]}, {'title': 'Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '61.24', 'spread': '9.87', 'groupId': 'BG000'}, {'value': '60.94', 'spread': '11.11', 'groupId': 'BG001'}, {'value': '60.00', 'spread': '10.95', 'groupId': 'BG002'}, {'value': '60.75', 'spread': '10.58', 'groupId': 'BG003'}]}]}, {'title': 'Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '62.00', 'spread': '11.56', 'groupId': 'BG000'}, {'value': '73.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated from data for a single participant.', 'groupId': 'BG001'}, {'value': '58.55', 'spread': '14.98', 'groupId': 'BG002'}, {'value': '60.54', 'spread': '13.31', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline characteristics were analyzed for all participants, treatment-naive participants, and previously treated participants. This analysis included participants who had received at least one dose of study drug and had non-missing assessments at baseline.'}, {'title': 'Previous Macular Laser Treatment Status', 'classes': [{'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '227', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Previous Macular Laser Treatment', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'No Previous Macular Laser Treatment', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}]}]}, {'title': 'Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Previous Macular Laser Treatment', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'No Previous Macular Laser Treatment', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}]}, {'title': 'Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Previous Macular Laser Treatment', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'No Previous Macular Laser Treatment', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics were analyzed for all participants, treatment-naive participants, and previously treated participants.'}, {'title': 'Mean Foveal Center Point Thickness at Baseline', 'classes': [{'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '224', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '459.88', 'spread': '162.09', 'groupId': 'BG000'}, {'value': '494.64', 'spread': '200.51', 'groupId': 'BG001'}, {'value': '440.50', 'spread': '150.42', 'groupId': 'BG002'}, {'value': '461.49', 'spread': '168.97', 'groupId': 'BG003'}]}]}, {'title': 'Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '464.19', 'spread': '166.00', 'groupId': 'BG000'}, {'value': '497.78', 'spread': '201.02', 'groupId': 'BG001'}, {'value': '456.70', 'spread': '156.12', 'groupId': 'BG002'}, {'value': '472.97', 'spread': '175.37', 'groupId': 'BG003'}]}]}, {'title': 'Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '451.82', 'spread': '156.87', 'groupId': 'BG000'}, {'value': '325.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated from data for a single participant.', 'groupId': 'BG001'}, {'value': '412.02', 'spread': '137.83', 'groupId': 'BG002'}, {'value': '430.82', 'spread': '147.49', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Foveal center point thickness (FCPT) is defined as the thickness from the inner limiting membrane to the retinal pigment epithelial at the horizontal slice closest to the center of the fovea. Foveal center point thickness was measured using spectral domain optical coherence tomography (SD-OCT).', 'unitOfMeasure': 'micrometers', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline characteristics were analyzed for all participants, treatment-naive participants, and previously treated participants. This analysis included participants who had received at least one dose of study drug and had non-missing assessments at baseline.'}, {'title': 'Mean Central Subfield Thickness at Baseline', 'classes': [{'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '224', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '489.01', 'spread': '136.74', 'groupId': 'BG000'}, {'value': '532.89', 'spread': '162.72', 'groupId': 'BG001'}, {'value': '485.31', 'spread': '130.10', 'groupId': 'BG002'}, {'value': '498.46', 'spread': '142.04', 'groupId': 'BG003'}]}]}, {'title': 'Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '490.88', 'spread': '139.01', 'groupId': 'BG000'}, {'value': '535.44', 'spread': '163.13', 'groupId': 'BG001'}, {'value': '496.47', 'spread': '134.96', 'groupId': 'BG002'}, {'value': '507.39', 'spread': '146.71', 'groupId': 'BG003'}]}]}, {'title': 'Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '485.52', 'spread': '134.56', 'groupId': 'BG000'}, {'value': '395.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated from data for a single participant.', 'groupId': 'BG001'}, {'value': '465.69', 'spread': '120.86', 'groupId': 'BG002'}, {'value': '474.61', 'spread': '126.79', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Central subfield thickness (CST) is defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield. Central subfield thickness was measured using SD-OCT.', 'unitOfMeasure': 'micrometers', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline characteristics were analyzed for all participants, treatment-naive participants, and previously treated participants. This analysis included participants who had received at least one dose of study drug and had non-missing assessments at baseline.'}, {'title': 'Number of Participants with Absence/Presence of Subretinal Fluid in the Study Eye at Baseline', 'classes': [{'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '224', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Subretinal Fluid Absent', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '123', 'groupId': 'BG003'}]}, {'title': 'Subretinal Fluid Present', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}]}, {'title': 'Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Subretinal Fluid Absent', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}, {'title': 'Subretinal Fluid Present', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}]}, {'title': 'Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Subretinal Fluid Absent', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}, {'title': 'Subretinal Fluid Present', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Subretinal fluid is defined as the presence of fluid between the retina and the retinal pigment epithelium. Resolution of subretinal fluid was measured using SD-OCT.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics were analyzed for all participants, treatment-naive participants, and previously treated participants. This analysis included participants who had received at least one dose of study drug and had non-missing assessments at baseline.'}, {'title': 'Number of Participants with Absence/Presence of Intraretinal Fluid at Baseline', 'classes': [{'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '221', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Intraretinal Fluid Absent', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Intraretinal Fluid Present', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '220', 'groupId': 'BG003'}]}]}, {'title': 'Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Intraretinal Fluid Absent', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Intraretinal Fluid Present', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}]}, {'title': 'Previously Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Intraretinal Fluid Absent', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Intraretinal Fluid Present', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Intraretinal fluid is described as the presence of fluid within the retina. Resolution of intraretinal fluid was measured by SD-OCT.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics were analyzed for all participants, treatment-naive participants, and previously treated participants. This analysis included participants who had received at least one dose of study drug and had non-missing assessments at baseline.'}], 'populationDescription': 'Two participants randomized to Arm C: 6 mg Faricimab were excluded from the analysis populations due to Good Clinical Practice (GCP) non-compliance at a single site.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-18', 'size': 2533555, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-08-31T10:24', 'hasProtocol': True}, {'date': '2017-07-31', 'size': 729294, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-08-31T10:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 229}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'dispFirstSubmitDate': '2018-09-14', 'completionDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2016-03-01', 'dispFirstSubmitQcDate': '2018-09-14', 'resultsFirstSubmitDate': '2020-08-31', 'studyFirstSubmitQcDate': '2016-03-01', 'dispFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-31', 'studyFirstPostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in BCVA Letter Score at Week 24, in Treatment-Naive Participants', 'timeFrame': 'Baseline, Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The primary analysis used a Linear Mixed Effects Model for Repeated Measurements. Missing values were not imputed; it was assumed that the data were missing at random."}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in BCVA Letter Score at Week 24, in Previously Treated Participants', 'timeFrame': 'Baseline, Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The primary analysis used a Linear Mixed Effects Model for Repeated Measurements. Missing values were not imputed; it was assumed that the data were missing at random."}, {'measure': 'Mean Change From Baseline in BCVA Letter Score at Week 24, in All Participants', 'timeFrame': 'Baseline, Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The primary analysis used a Linear Mixed Effects Model for Repeated Measurements. Missing values were not imputed; it was assumed that the data were missing at random."}, {'measure': 'Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in Treatment-Naive Participants', 'timeFrame': 'Baseline, Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random."}, {'measure': 'Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in Previously Treated Participants', 'timeFrame': 'Baseline up to Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random."}, {'measure': 'Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in All Participants', 'timeFrame': 'Baseline up to Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random."}, {'measure': 'Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in Treatment-Naive Participants', 'timeFrame': 'Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random."}, {'measure': 'Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in Previously Treated Participants', 'timeFrame': 'Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random."}, {'measure': 'Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in All Participants', 'timeFrame': 'Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random."}, {'measure': 'Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in Treatment-Naive Participants', 'timeFrame': 'Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random."}, {'measure': 'Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in Previously Treated Participants', 'timeFrame': 'Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random."}, {'measure': 'Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in All Participants', 'timeFrame': 'Week 24', 'description': "Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random."}, {'measure': 'Mean Change From Baseline in Foveal Center Point Thickness at Week 24, in Treatment-Naive Participants', 'timeFrame': 'Baseline, Week 24', 'description': 'Foveal center point thickness (FCPT) is defined as the thickness from the inner limiting membrane to the retinal pigment epithelial at the horizontal slice closest to the center of the fovea. Foveal center point thickness was measured using spectral domain optical coherence tomography (SD-OCT).'}, {'measure': 'Mean Change From Baseline in Foveal Center Point Thickness at Week 24, in Previously Treated Participants', 'timeFrame': 'Baseline, Week 24', 'description': 'Foveal center point thickness (FCPT) is defined as the thickness from the inner limiting membrane to the retinal pigment epithelial at the horizontal slice closest to the center of the fovea. Foveal center point thickness was measured using spectral domain optical coherence tomography (SD-OCT).'}, {'measure': 'Mean Change From Baseline in Foveal Center Point Thickness at Week 24, in All Participants', 'timeFrame': 'Baseline, Week 24', 'description': 'Foveal center point thickness (FCPT) is defined as the thickness from the inner limiting membrane to the retinal pigment epithelial at the horizontal slice closest to the center of the fovea. Foveal center point thickness was measured using spectral domain optical coherence tomography (SD-OCT).'}, {'measure': 'Mean Change From Baseline in Central Subfield Thickness at Week 24, in Treatment-Naive Participants', 'timeFrame': 'Baseline, Week 24', 'description': 'Central subfield thickness (CST) is defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield. Central subfield thickness was measured using SD-OCT.'}, {'measure': 'Mean Change From Baseline in Central Subfield Thickness at Week 24, in Previously Treated Participants', 'timeFrame': 'Baseline, Week 24', 'description': 'Central subfield thickness (CST) is defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield. Central subfield thickness was measured using SD-OCT.'}, {'measure': 'Mean Change From Baseline in Central Subfield Thickness at Week 24, in All Participants', 'timeFrame': 'Baseline, Week 24', 'description': 'Central subfield thickness (CST) is defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield. Central subfield thickness was measured using SD-OCT.'}, {'measure': 'Percentage of Participants With Presence of Subretinal Fluid in the Study Eye at Week 24, in Treatment-Naive Participants', 'timeFrame': 'Week 24', 'description': 'Subretinal fluid is defined as the presence of fluid between the retina and the retinal pigment epithelium. Resolution of subretinal fluid was measured using SD-OCT.'}, {'measure': 'Percentage of Participants With Presence of Subretinal Fluid in the Study Eye at Week 24, in Previously Treated Participants', 'timeFrame': 'Week 24', 'description': 'Subretinal fluid is defined as the presence of fluid between the retina and the retinal pigment epithelium. Resolution of subretinal fluid was measured using SD-OCT.'}, {'measure': 'Percentage of Participants With Presence of Intraretinal Fluid in the Study Eye at Week 24, in Treatment-Naive Participants', 'timeFrame': 'Week 24', 'description': 'Intraretinal fluid is described as the presence of fluid within the retina. Resolution of intraretinal fluid was measured by SD-OCT.'}, {'measure': 'Percentage of Participants With Presence of Intraretinal Fluid in the Study Eye at Week 24, in Previously Treated Participants', 'timeFrame': 'Week 24', 'description': 'Intraretinal fluid is described as the presence of fluid within the retina. Resolution of intraretinal fluid was measured by SD-OCT.'}, {'measure': 'Number of Participants With Presence or Absence of Leakage at the Macula at Week 24, in Treatment-Naive Participants', 'timeFrame': 'Week 24', 'description': 'Leakage at the macula describes the leakage of fluorescein at the macula region as measured by fundus fluorescein angiography (FFA).'}, {'measure': 'Number of Participants With Presence or Absence of Leakage at the Macula at Week 24, in Previously Treated Participants', 'timeFrame': 'Week 24', 'description': 'Leakage at the macula describes the leakage of fluorescein at the macula region as measured by fundus fluorescein angiography (FFA).'}, {'measure': 'Mean Change From Baseline in the Size of the Foveal Avascular Zone at Week 24, in All Participants', 'timeFrame': 'Baseline, Week 24', 'description': 'The size of the foveal avascular zone was to be measured by fundus fluorescein angiography (FFA).'}, {'measure': 'Mean Plasma Concentrations of Ranibizumab (Arm A) or Faricimab (Arms B and C) Over Time, in All Participants', 'timeFrame': 'Predose at Baseline and Weeks 1, 4, 12, 20, 24, 26, 28, 32, and 36', 'description': 'Plasma concentrations of ranibizumab were measured by an appropriate assay only from samples of participants randomized to Arm A: 0.3 mg Ranibizumab. Plasma concentrations of faricimab were measured by a specific validated enzyme-linked immunoabsorbent assay (ELISA) only from samples of participants randomized to Arm B: 1.5 mg Faricimab and Arm C: 6 mg Faricimab. Baseline was defined as the last non-missing predose assessment. The lower limit of quantification (LLOQ) for the ranibizumab and faricimab assays were 0.015 nanograms per millilitre (ng/mL) and 0.800 ng/mL, respectively. Values below the limit of quantification were imputed as LLOQ divided by 2.'}, {'measure': 'Baseline and Change From Baseline in Free Vascular Endothelial Growth Factor (VEGF) Plasma Levels Over Time, in Treatment-Naive Participants', 'timeFrame': 'Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36', 'description': 'The concentration of free VEGF was determined in plasma samples using an enzyme-linked immunosorbent assay (ELISA) method. The lower limit of quantification (LLOQ) of the assay was 15.6 picograms per millilitre (pg/mL). Plasma free VEGF concentrations below the limit of quantification were imputed as LLOQ divided by 2.'}, {'measure': 'Baseline and Change From Baseline in Free Vascular Endothelial Growth Factor (VEGF) Plasma Levels Over Time, in Previously Treated Participants', 'timeFrame': 'Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36', 'description': 'The concentration of free VEGF was determined in plasma samples using an enzyme-linked immunosorbent assay (ELISA) method. The lower limit of quantification (LLOQ) of the assay was 15.6 picograms per millilitre (pg/mL). Plasma free VEGF concentrations below the limit of quantification were imputed as LLOQ divided by 2.'}, {'measure': 'Baseline and Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Levels Over Time, in Treatment-Naive Participants', 'timeFrame': 'Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36', 'description': 'Total Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.09 nanograms per millilitre (ng/mL). Plasma total Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2.'}, {'measure': 'Baseline and Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Levels Over Time, in Treatment-Naive Participants', 'timeFrame': 'Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36', 'description': 'Free Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.9 nanograms per millilitre (ng/mL). Plasma free Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2.'}, {'measure': 'Baseline and Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Levels Over Time, in Previously Treated Participants', 'timeFrame': 'Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36', 'description': 'Total Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.09 nanograms per millilitre (ng/mL). Plasma total Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2.'}, {'measure': 'Baseline and Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Levels Over Time, in Previously Treated Participants', 'timeFrame': 'Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36', 'description': 'Free Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.9 nanograms per millilitre (ng/mL). Plasma free Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2.'}, {'measure': 'Safety Summary of the Number of Participants With at Least One Adverse Event During the Treatment Period (up to Week 24), in All Participants', 'timeFrame': 'From Baseline up to Week 24', 'description': 'This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) within 28 days of the end of the treatment period (i.e., up to Week 24). AEs are categorized as any AEs, ocular AEs occurring in the study eye or fellow eye, systemic AEs, serious AEs, AEs related to treatment with study drug, AEs leading to discontinuation of treatment with study drug, and AEs with fatal outcome. Multiple occurrences of the same AE in one individual were counted only once.'}, {'measure': 'Safety Summary of the Number of Participants With at Least One Adverse Event During the Post-Treatment Observation Period, in All Participants', 'timeFrame': 'From Week 24 up to Week 36', 'description': 'This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) during the post-treatment observation period (i.e., from Week 24 up to Week 36). AEs are categorized as any AEs, ocular AEs occurring in the study eye or fellow eye, systemic AEs, serious AEs, AEs related to treatment with study drug, AEs leading to discontinuation of treatment with study drug, and AEs with fatal outcome. Multiple occurrences of the same AE in one individual were counted only once.'}, {'measure': 'Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye During the Treatment Period by Highest Intensity, in All Participants', 'timeFrame': 'From Baseline up to Week 24', 'description': 'The investigator assessed adverse event severity according to the following grading scale: Mild = Discomfort noticed, but no disruption of normal daily activity; Moderate = Discomfort sufficient to reduce or affect normal daily activity; Severe = Incapacitating with inability to work or to perform normal daily activity. Only the most severe intensity was counted for multiple occurrences of the same adverse event per participant at the preferred term level. Severity and seriousness are not synonymous; regardless of severity, some adverse events may have also met seriousness criteria.'}, {'measure': 'Number of Participants With at Least One Systemic Adverse Event During the Treatment Period by Highest Intensity, in All Participants', 'timeFrame': 'From Baseline up to Week 24', 'description': 'The investigator assessed adverse event severity according to the following grading scale: Mild = Discomfort noticed, but no disruption of normal daily activity; Moderate = Discomfort sufficient to reduce or affect normal daily activity; Severe = Incapacitating with inability to work or to perform normal daily activity. Only the most severe intensity was counted for multiple occurrences of the same adverse event per participant at the preferred term level. Severity and seriousness are not synonymous; regardless of severity, some adverse events may have also met seriousness criteria.'}, {'measure': 'Number of Participants With Abnormal Systolic Blood Pressure Over Time, in All Participants', 'timeFrame': 'Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 26, 28, 32, and 36', 'description': 'Abnormal systolic blood pressure (supine) was defined as any value outside of the standard reference range, from \\<70 (low) to \\>180 (high) millimetres of mercury (mmHg) or a change from baseline of greater than 30 mmHg (decrease or increase). Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.'}, {'measure': 'Number of Participants With Abnormal Diastolic Blood Pressure Over Time, in All Participants', 'timeFrame': 'Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 26, 28, 32, and 36', 'description': 'Abnormal diastolic blood pressure (supine) was defined as any value outside of the standard reference range, from \\<40 (low) to \\>110 (high) millimetres of mercury (mmHg) or a change from baseline of greater than 20 mmHg (decrease or increase). Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.'}, {'measure': 'Number of Participants With an Abnormal Heart Rate Over Time, in All Participants', 'timeFrame': 'Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 26, 28, 32, and 36', 'description': 'Abnormal heart rate (supine) was defined as any value outside of the standard reference range, from \\<40 (low) to \\>100 (high) beats per minute. Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.'}, {'measure': 'Number of Participants With Abnormal Body Temperature Over Time, in All Participants', 'timeFrame': 'Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 26, 28, 32, and 36', 'description': 'Abnormal body temperature (supine) was defined as any value outside of the standard reference range, from \\<36.5 (low) to \\>37.5 (high) degrees Celsius. Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.'}, {'measure': 'Mean Heart Rate at Baseline and Week 24, as Measured by Electrocardiogram in All Participants', 'timeFrame': 'Baseline, Week 24', 'description': 'Triplicate 12-lead electrocardiogram (ECG), i.e., three useful ECGs without artifacts, were performed on all evaluable participants. To minimize variability, it was important that participants be in a resting position for at least 10 minutes prior to the ECG evaluation. Body position was to be consistently maintained for each ECG evaluation to prevent changes in heart rate. Environmental distractions (e.g., television, radio, conversation, mobile phones) were to be minimized before and during ECG recording. Triplicate ECGs were to be obtained within a 5-minute interval. The predefined standard reference range for heart rate measured by ECG was 40 (low) to 100 (high) beats per minute.'}, {'measure': 'Mean PR, RR, QT, QRS, QTcB, and QTcF Intervals at Baseline and Week 24, as Measured by Electrocardiogram in All Participants', 'timeFrame': 'Baseline, Week 24', 'description': 'Triplicate 12-lead electrocardiogram (ECG), i.e., three useful ECGs without artifacts, were performed on all evaluable participants. To minimize variability, it was important that participants be in a resting position for at least 10 minutes prior to the ECG evaluation. Body position was to be consistently maintained for each ECG evaluation to prevent changes in heart rate. Environmental distractions (e.g., television, radio, conversation, mobile phones) were to be minimized before and during ECG recording. Triplicate ECGs were to be obtained within a 5-minute interval. Baseline was defined as the last non-missing predose assessment. The predefined standard reference ranges for the intervals measured by ECG were defined as follows (ranges are from low to high, in milliseconds \\[msec\\]): PR: 120-200 msec; RR: 600-1500 msec; QT: 200-500 msec; QRS: 40-120 msec.'}, {'measure': 'Number of Participants With Marked Laboratory Abnormalities in Hematology Tests, in All Participants', 'timeFrame': 'Predose at Baseline, Weeks 12 and 24, and at Early Termination and Unscheduled Visits (up to 36 weeks)', 'description': "Clinical laboratory tests for hematology parameters were performed and any marked abnormal values (High or Low) were based on Roche's predefined standard reference ranges. Marked laboratory abnormalities are presented according to COG3007 abnormality criteria: Single, Not Last = abnormality detected at a single assessment, but not at the last assessment; Last or Replicated = abnormality detected at the last assessment or replicated at one or more assessments. Not every laboratory abnormality qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. Abs. = absolute count; Ery. = erythrocyte; Hemo. = hemoglobin"}, {'measure': 'Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants', 'timeFrame': 'Predose at Baseline, Weeks 12 and 24, and at Early Termination and Unscheduled Visits (up to 36 weeks)', 'description': "Clinical laboratory tests for blood chemistry parameters were performed and any marked abnormal values (High or Low) were based on Roche's predefined standard reference ranges. Marked laboratory abnormalities are presented according to COG3007 abnormality criteria: Single, Not Last = abnormality detected at a single assessment, but not at the last assessment; Last or Replicated = abnormality detected at the last assessment or replicated at one or more assessments. Not every laboratory abnormality qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. SGOT/AST = serum glutamic oxaloacetic transaminase / aspartate aminotransferase"}, {'measure': 'Number of Participants With Marked Laboratory Abnormalities in Coagulation Tests, in All Participants', 'timeFrame': 'Predose at Baseline, Weeks 12 and 24, and at Early Termination and Unscheduled Visits (up to 36 weeks)', 'description': "Clinical laboratory tests for coagulation parameters were performed and any marked abnormal values (High or Low) were based on Roche's predefined standard reference ranges. Marked laboratory abnormalities are presented according to COG3007 abnormality criteria: Single, Not Last = abnormality detected at a single assessment, but not at the last assessment; Last or Replicated = abnormality detected at the last assessment or replicated at one or more assessments. Not every laboratory abnormality qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. aPTT = activated partial thromboplastin time; INR = International Normalized Ratio (prothrombin time)"}, {'measure': 'Number of Participants Who Tested Negative or Positive for Anti-Drug Antibodies Against Faricimab Over Time', 'timeFrame': 'Baseline and Weeks 1, 4, 12, 16, 20, 24, 26, 28, 32, and 36', 'description': 'The number and percentage of participants who tested negative or positive for plasma anti-drug antibodies (ADA) to faricimab at baseline and at the study visits was tabulated, except for those who were randomized to treatment with ranibizumab in Arm A.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema']}, 'referencesModule': {'references': [{'pmid': '30905643', 'type': 'DERIVED', 'citation': 'Sahni J, Patel SS, Dugel PU, Khanani AM, Jhaveri CD, Wykoff CC, Hershberger VS, Pauly-Evers M, Sadikhov S, Szczesny P, Schwab D, Nogoceke E, Osborne A, Weikert R, Fauser S. Simultaneous Inhibition of Angiopoietin-2 and Vascular Endothelial Growth Factor-A with Faricimab in Diabetic Macular Edema: BOULEVARD Phase 2 Randomized Trial. Ophthalmology. 2019 Aug;126(8):1155-1170. doi: 10.1016/j.ophtha.2019.03.023. Epub 2019 Mar 21.'}]}, 'descriptionModule': {'briefSummary': 'This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 36-week study in participants with center-involving diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA) will be defined as the study eye. The study will consist of a treatment period (20 weeks) and an observational period (up to 16 weeks). Treatment naive participants will be randomized in a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in a 1:1 ratio to Arms A and C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Macular edema associated with diabetic retinopathy\n* Decreased visual acuity attributable primarily to DME\n* Diagnosis of diabetes mellitus\n\nExclusion Criteria:\n\n* High risk proliferative diabetic retinopathy\n* Cataract surgery within 3 months of Baseline, or any other previous intraocular surgery\n* Uncontrolled glaucoma\n* Current or history of ocular disease in the study eye other than DME\n* Major illness or major surgical procedure within 1 month prior to Day 1\n* Uncontrolled blood pressure\n* Glycosylated hemoglobin (HbA1c) greater than (\\>) 12 percent (%) at screening\n* Untreated diabetes mellitus or initiation of oral anti-diabetic medication or insulin within 4 months prior to Day 1'}, 'identificationModule': {'nctId': 'NCT02699450', 'acronym': 'BOULEVARD', 'briefTitle': 'A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multiple-Center, Multiple-Dose, Randomized, Active Comparator-Controlled, Double-Masked, Parallel Group, 36-Week Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO6867461 Administered Intravitreally in Patients With Diabetic Macular Edema', 'orgStudyIdInfo': {'id': 'BP30099'}, 'secondaryIdInfos': [{'id': 'RG7716', 'type': 'OTHER', 'domain': 'Roche theme number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A: 0.3 mg Ranibizumab', 'description': 'Participants will receive 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.', 'interventionNames': ['Drug: Ranibizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: 1.5 mg Faricimab', 'description': 'Participants will receive 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.', 'interventionNames': ['Drug: Faricimab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C: 6 mg Faricimab', 'description': 'Participants will receive 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.', 'interventionNames': ['Drug: Faricimab']}], 'interventions': [{'name': 'Faricimab', 'type': 'DRUG', 'otherNames': ['RO6867461', 'RG7716'], 'description': 'Faricimab will be administered by IVT injection in the study eye.', 'armGroupLabels': ['Arm B: 1.5 mg Faricimab', 'Arm C: 6 mg Faricimab']}, {'name': 'Ranibizumab', 'type': 'DRUG', 'otherNames': ['Lucentis'], 'description': 'Ranibizumab will be administered by IVT injection in the study eye.', 'armGroupLabels': ['Arm A: 0.3 mg Ranibizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85014', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retinal Research Institute, LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Associated Retina Consultants', 'geoPoint': 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