Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-25 @ 11:43 AM
Study NCT ID:
NCT00509795
Status:
COMPLETED
Last Update Posted:
2012-12-28
First Post:
2007-07-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'C533178', 'term': 'aflibercept'}], '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': 'clinicaltrials@regeneron.com', 'title': 'Clinical Trials Administrator', 'organization': 'Regeneron Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'After completion of the trial, the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review; provided that the sponsor can remove confidential or proprietary information from such communications. The sponsor cannot require other changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks.', 'description': 'Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.', 'eventGroups': [{'id': 'EG000', 'title': 'Ranibizumab 0.5mg Q4', 'description': 'Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of ranibizumab (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.', 'otherNumAtRisk': 304, 'otherNumAffected': 261, 'seriousNumAtRisk': 304, 'seriousNumAffected': 94}, {'id': 'EG001', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4', 'description': 'Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.', 'otherNumAtRisk': 304, 'otherNumAffected': 254, 'seriousNumAtRisk': 304, 'seriousNumAffected': 70}, {'id': 'EG002', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4', 'description': 'Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.', 'otherNumAtRisk': 304, 'otherNumAffected': 262, 'seriousNumAtRisk': 304, 'seriousNumAffected': 88}, {'id': 'EG003', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8', 'description': 'Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.', 'otherNumAtRisk': 303, 'otherNumAffected': 258, 'seriousNumAtRisk': 303, 'seriousNumAffected': 90}], 'otherEvents': [{'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 17}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 33}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'ATRIOVENTRICULAR BLOCK FIRST DEGREE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 9}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'UPPER RESPIRATORY TRACT Infections and infestationsION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'URINARY TRACT Infections and infestationsION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 21}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'Blood and lymphatic system disorders GLUCOSE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'AGE-RELATED MACULAR DEGENERATION', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 15}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'BLEPHARITIS', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'CATARACT', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'CHOROIDAL NEOVASCULARISATION', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'CONJUNCTIVAL HAEMORRHAGE', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 19}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'MACULAR DEGENERATION', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'RETINAL HAEMORRHAGE', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 22}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'RETINAL OEDEMA', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'VISUAL ACUITY REDUCED', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 19}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'VITREOUS DETACHMENT', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 24}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'INTRAOCULAR PRESSURE INCREASED', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'DRY Eye disorders', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'Eye disorders IRRITATION', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 16}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'Eye disorders PAIN', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 31}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'Eye disorders PRURITUS', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'FOREIGN BODY SENSATION IN Eye disordersS', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 19}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'LACRIMATION INCREASED', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 16}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'RETINAL PIGMENT EPITHELIOPATHY', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'VISION BLURRED', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'VITREOUS FLOATERS', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 29}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'COAGULOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'ARTHROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'CERVICAL SPINAL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'INTERVERTEBRAL DISC DEGENERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'LUMBAR SPINAL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'OSTEONECROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'RHABDOMYOLYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'SPINAL COLUMN STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'SPINAL OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'SPONDYLOLISTHESIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'ATYPICAL FIBROXANTHOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'B-CELL LYMPHOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'BLADDER TRANSITIONAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'BLADDER TRANSITIONAL CELL CARCINOMA RECURRENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'BRAIN NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'BREAST Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'BREAST Neoplasms benign, malignant and unspecified (incl cysts and polyps) IN SITU', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'BRONCHIOLOALVEOLAR CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'CARDIAC MYXOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'CHRONIC LYMPHOCYTIC LEUKAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'COLON Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'COLON Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECURRENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'ENDOMETRIAL Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'HEPATIC Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'HEPATIC NEOPLASM MALIGNANT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'LEUKAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'LUNG NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'LUNG NEOPLASM MALIGNANT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'LUNG SQUAMOUS CELL CARCINOMA STAGE II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'MALIGNANT MELANOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'METASTASES TO CENTRAL NERVOUS SYSTEM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'METASTASES TO Hepatobiliary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'METASTASES TO LUNG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'METASTASES TO LYMPH NODES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'METASTATIC NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'NEOPLASM MALIGNANT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'NON-SMALL CELL LUNG Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'NON-SMALL CELL LUNG Neoplasms benign, malignant and unspecified (incl cysts and polyps) STAGE IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'OESOPHAGEAL ADENOCARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'PROSTATE Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'PROSTATE Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'RECTAL Neoplasms benign, malignant and unspecified (incl cysts and polyps) STAGE III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'RECTOSIGMOID Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'RENAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'SALIVARY GLAND Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECURRENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'SMALL CELL LUNG Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'SMALL CELL LUNG Neoplasms benign,malignant & unspecified(incl cysts and polyps)STAGE UNSPECIFIED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'SQUAMOUS CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'SQUAMOUS CELL CARCINOMA OF Skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'THYROID Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'TONSIL Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'TRANSITIONAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'TUMOUR HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': "WALDENSTROM'S MACROGLOBULINAEMIA", 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'AORTIC ANEURYSM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'AORTIC ANEURYSM RUPTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'AORTIC STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'ARTERIOSCLEROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'FEMORAL ARTERY ANEURYSM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, 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OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'LYMPHATIC FISTULA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'LYMPHOCELE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 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'PERIPHERAL VASCULAR DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'PHLEBITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'PHLEBITIS DEEP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 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{'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'ABDOMINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'ABDOMINAL HERNIA OBSTRUCTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 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'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'COLONIC POLYP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, 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[{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'CONJUNCTIVITIS', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'MACULAR DEGENERATION', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'MACULOPATHY', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'POSTERIOR CAPSULE OPACIFICATION', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'RETINAL DETACHMENT', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'RETINAL HAEMORRHAGE', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'RETINAL OEDEMA', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'RETINAL TEar and labyrinth disorders', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'UVEITIS', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'VISUAL ACUITY REDUCED', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'VITREOUS DETACHMENT', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'ENDOPHTHALMITIS', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'INTRAOCULAR PRESSURE INCREASED', 'notes': 'Ocular Fellow Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'ANGLE CLOSURE GLAUCOMA', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'BLINDNESS TRANSIENT', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'CHOROIDAL HAEMORRHAGE', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'DRY Eye disorders', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'Eye disorders IRRITATION', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'Eye disorders PAIN', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'Eye disorders PRURITUS', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'FOREIGN BODY SENSATION IN Eye disordersS', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'KERATITIS', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'LACRIMATION INCREASED', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'MACULAR HOLE', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'PSEUDOENDOPHTHALMITIS', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'RETINAL DEGENERATION', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'RETINAL PIGMENT EPITHELIAL TEar and labyrinth disorders', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'RETINAL PIGMENT EPITHELIOPATHY', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'VISION BLURRED', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'VITREOUS FLOATERS', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'VITREOUS HAEMORRHAGE', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}, {'term': 'INCORRECT DOSE ADMINISTERED', 'notes': 'Ocular Study Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra Version 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}, {'value': '265', 'groupId': 'OG003'}, {'value': '1089', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5mg Q4', 'description': 'Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.'}, {'id': 'OG001', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4', 'description': 'Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.'}, {'id': 'OG002', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4', 'description': 'Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.'}, {'id': 'OG003', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8', 'description': 'Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.'}, {'id': 'OG004', 'title': 'Total'}], 'classes': [{'categories': [{'measurements': [{'value': '94.4', 'spread': '0', 'groupId': 'OG000'}, {'value': '95.1', 'spread': '0', 'groupId': 'OG001'}, {'value': '95.9', 'spread': '0', 'groupId': 'OG002'}, {'value': '95.1', 'spread': '0', 'groupId': 'OG003'}, {'value': '95.1', 'spread': '0', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.1', 'paramValue': '-0.7', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '3.1', 'estimateComment': 'The difference is calculated as ranibizumab minus IAI. A positive value favors IAI 2.0Q4. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.', 'groupDescription': 'The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.1', 'paramValue': '-1.5', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '2.1', 'estimateComment': 'The difference is calculated as ranibizumab minus IAI. A negative value favors the IAI 0.5Q4 group. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.', 'groupDescription': 'The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI (EYLEA, VEGF Trap-Eye).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.1', 'paramValue': '-0.7', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '3.1', 'estimateComment': 'The difference is calculated as ranibizumab minus IAI. A negative value favors the IAI 2.0Q8 group. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.', 'groupDescription': 'The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI (EYLEA, VEGF Trap-Eye).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and at week 52', 'description': 'Defined "maintenance of vision" as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS population used for analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '301', 'groupId': 'OG003'}, {'value': '1210', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5mg Q4', 'description': 'Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.'}, {'id': 'OG001', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4', 'description': 'Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.'}, {'id': 'OG002', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4', 'description': 'Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.'}, {'id': 'OG003', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8', 'description': 'Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.'}, {'id': 'OG004', 'title': 'Total'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '15.25', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '13.77', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '13.41', 'groupId': 'OG002'}, {'value': '7.9', 'spread': '15.00', 'groupId': 'OG003'}, {'value': '8.5', 'spread': '14.44', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0054', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Differences in Least Squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.1', 'paramValue': '3.15', 'ciLowerLimit': '0.92', 'ciUpperLimit': '5.37', 'pValueComment': 'As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049', 'estimateComment': 'The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.', 'groupDescription': 'The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4793', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Differences in Least Squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.1', 'paramValue': '0.80', 'ciLowerLimit': '-3.03', 'ciUpperLimit': '1.43', 'pValueComment': 'As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049', 'estimateComment': 'The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.', 'groupDescription': 'The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8179', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Differences in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.1', 'paramValue': '0.26', 'ciLowerLimit': '-1.97', 'ciUpperLimit': '2.49', 'pValueComment': 'As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049', 'estimateComment': 'The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q8.', 'groupDescription': 'The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at week 52', 'description': 'Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.', 'unitOfMeasure': 'letters read', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population used for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '301', 'groupId': 'OG003'}, {'value': '1210', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5mg Q4', 'description': 'Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.'}, {'id': 'OG001', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4', 'description': 'Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.'}, {'id': 'OG002', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4', 'description': 'Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.'}, {'id': 'OG003', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8', 'description': 'Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.'}, {'id': 'OG004', 'title': 'Total'}], 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'spread': '0', 'groupId': 'OG000'}, {'value': '37.5', 'spread': '0', 'groupId': 'OG001'}, {'value': '24.9', 'spread': '0', 'groupId': 'OG002'}, {'value': '30.6', 'spread': '0', 'groupId': 'OG003'}, {'value': '31.1', 'spread': '0', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.1042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.1', 'paramValue': '6.6', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '14.1', 'pValueComment': 'As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.', 'estimateComment': 'The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.', 'groupDescription': 'The null hypothesis is that both percentages are equal.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1037', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.1', 'paramValue': '-6.0', 'ciLowerLimit': '-13.2', 'ciUpperLimit': '1.2', 'pValueComment': 'As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.', 'estimateComment': 'The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.', 'groupDescription': 'The null hypothesis is that both percentages are equal.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.93', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.1', 'paramValue': '-0.4', 'ciLowerLimit': '-7.7', 'ciUpperLimit': '7.0', 'pValueComment': 'As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.', 'estimateComment': 'The difference is calculated as VEGF Trap-Eye minus ranibizumab. A positive value favors VEGF Trap-Eye 2.0Q8.', 'groupDescription': 'The pairwise The null hypothesis is that both percentages are equal.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and at week 52', 'description': 'Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population used for analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '301', 'groupId': 'OG003'}, {'value': '1210', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5mg Q4', 'description': 'Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.'}, {'id': 'OG001', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4', 'description': 'Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.'}, {'id': 'OG002', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4', 'description': 'Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.'}, {'id': 'OG003', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8', 'description': 'Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.'}, {'id': 'OG004', 'title': 'Total'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '14.01', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '13.50', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '11.87', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '14.74', 'groupId': 'OG003'}, {'value': '5.3', 'spread': '13.59', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.2090', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Differences Least Squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.1', 'paramValue': '1.28', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '3.28', 'pValueComment': 'As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049', 'estimateComment': 'The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.', 'groupDescription': 'The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5128', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Differences in Least Squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.1', 'paramValue': '-0.67', 'ciLowerLimit': '-2.69', 'ciUpperLimit': '1.35', 'pValueComment': 'As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049', 'estimateComment': 'The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.', 'groupDescription': 'The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5579', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Differences in Least Squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.1', 'paramValue': '-0.60', 'ciLowerLimit': '-2.61', 'ciUpperLimit': '1.42', 'pValueComment': 'As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049', 'estimateComment': 'The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q8.', 'groupDescription': 'The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at Week 52', 'description': 'The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population used for analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '301', 'groupId': 'OG003'}, {'value': '1210', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5mg Q4', 'description': 'Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.'}, {'id': 'OG001', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4', 'description': 'Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.'}, {'id': 'OG002', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4', 'description': 'Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.'}, {'id': 'OG003', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8', 'description': 'Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.'}, {'id': 'OG004', 'title': 'Total'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.2', 'spread': '5.59', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '5.47', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '5.27', 'groupId': 'OG002'}, {'value': '-3.4', 'spread': '6.02', 'groupId': 'OG003'}, {'value': '-3.9', 'spread': '5.61', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.3575', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Differences in Least Squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.1', 'paramValue': '-0.33', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '0.38', 'pValueComment': 'As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049', 'estimateComment': 'The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 2.0Q4', 'groupDescription': 'The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0507', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Differences in Least Squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.1', 'paramValue': '0.71', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '1.42', 'pValueComment': 'As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049', 'estimateComment': 'The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 0.5Q4', 'groupDescription': 'The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0173', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Differences in Least Squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.1', 'paramValue': '0.86', 'ciLowerLimit': '0.15', 'ciUpperLimit': '1.58', 'pValueComment': 'As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049', 'estimateComment': 'The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 2.0Q8', 'groupDescription': 'The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at week 52', 'description': 'CNV area values measured in square millimeters (mm\\^2); lower values represent better outcomes.', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population used for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ranibizumab 0.5mg Q4', 'description': 'Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year.'}, {'id': 'FG001', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4', 'description': 'Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.'}, {'id': 'FG002', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4', 'description': 'Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.'}, {'id': 'FG003', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8', 'description': 'Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and received sham injections at interim monthly visits.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '306'}, {'groupId': 'FG001', 'numSubjects': '304'}, {'groupId': 'FG002', 'numSubjects': '304'}, {'groupId': 'FG003', 'numSubjects': '303'}]}, {'type': 'Patients Received Treatment (SAF)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '304'}, {'groupId': 'FG001', 'numSubjects': '304'}, {'groupId': 'FG002', 'numSubjects': '304'}, {'groupId': 'FG003', 'numSubjects': '303'}]}, {'type': 'Full Analysis Set (FAS) Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '304'}, {'groupId': 'FG001', 'numSubjects': '304'}, {'groupId': 'FG002', 'numSubjects': '301'}, {'groupId': 'FG003', 'numSubjects': '301'}]}, {'type': 'Per Protocol Set (PPS) Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '269'}, {'groupId': 'FG001', 'numSubjects': '285'}, {'groupId': 'FG002', 'numSubjects': '270'}, {'groupId': 'FG003', 'numSubjects': '265'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '293'}, {'groupId': 'FG002', 'numSubjects': '277'}, {'groupId': 'FG003', 'numSubjects': '276'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'OTHER', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'The study was conducted at 164 sites in the United States and Canada. Recruitment period: 02 Aug 2007 to 15 Sep 2009.', 'preAssignmentDetails': '2063 patients were screened, 1217 randomized, and 1215 included in the Safety Analysis Set (SAF). The Full Analysis Set (FAS) included 1210 patients with at least 1 post-baseline assessment. The Per Protocol Set (PPS) included 1089 patients who received ≥ 9 doses of study drug and attended ≥ 9 scheduled visits during the first year.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}, {'value': '303', 'groupId': 'BG003'}, {'value': '1215', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Ranibizumab 0.5mg Q4', 'description': 'Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.'}, {'id': 'BG001', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4', 'description': 'Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.'}, {'id': 'BG002', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4', 'description': 'Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.'}, {'id': 'BG003', 'title': 'IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8', 'description': 'Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '78.2', 'spread': '7.59', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '77.7', 'spread': '7.93', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '78.3', 'spread': '8.10', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '77.9', 'spread': '8.39', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '78.0', 'spread': '8.00', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'SAF population used for analysis.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}, {'value': '714', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}, {'value': '501', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'spread': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '11', 'spread': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '11', 'spread': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '12', 'spread': '0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '41', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '297', 'groupId': 'BG000'}, {'value': '293', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}, {'value': '291', 'groupId': 'BG003'}, {'value': '1174', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'SAF population used for analysis.', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'spread': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'spread': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '2', 'spread': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '1', 'spread': '0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'spread': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '3', 'spread': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '5', 'spread': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '4', 'spread': '0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'spread': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'spread': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'spread': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '1', 'spread': '0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'spread': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '1', 'spread': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'spread': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '1', 'spread': '0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '296', 'spread': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '295', 'spread': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '294', 'spread': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '289', 'spread': '0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '1174', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'spread': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'spread': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'spread': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '1', 'spread': '0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'spread': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '5', 'spread': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '3', 'spread': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '6', 'spread': '0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '18', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'SAF population used for analysis.', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) total score', 'classes': [{'categories': [{'measurements': [{'value': '71.7', 'spread': '17.29', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '70.4', 'spread': '16.60', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '71.1', 'spread': '17.72', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '69.5', 'spread': '16.82', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '70.7', 'spread': '17.11', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'SAF population used for analysis. The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Area of Choroidal Neovascularization (CNV)', 'classes': [{'categories': [{'measurements': [{'value': '6.52', 'spread': '5.245', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '6.59', 'spread': '5.052', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '6.49', 'spread': '4.437', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '6.56', 'spread': '5.129', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '6.54', 'spread': '4.968', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'SAF population used for analysis.', 'unitOfMeasure': 'mm^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Lesion Type', 'classes': [{'title': 'Occult', 'categories': [{'measurements': [{'value': '115', 'spread': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '110', 'spread': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '123', 'spread': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '118', 'spread': '0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '466', 'groupId': 'BG004'}]}]}, {'title': 'Minimally Classic', 'categories': [{'measurements': [{'value': '101', 'spread': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '105', 'spread': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '97', 'spread': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '112', 'spread': '0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '415', 'groupId': 'BG004'}]}]}, {'title': 'Predominantly Classic', 'categories': [{'measurements': [{'value': '82', 'spread': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '87', 'spread': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '82', 'spread': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '71', 'spread': '0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '322', 'groupId': 'BG004'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '6', 'spread': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '2', 'spread': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '2', 'spread': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '2', 'spread': '0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'SAF population used for analysis.', 'unitOfMeasure': 'patients'}, {'title': 'Baseline Total Lesion Size', 'classes': [{'categories': [{'measurements': [{'value': '6.99', 'spread': '5.491', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '6.98', 'spread': '5.388', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '6.96', 'spread': '4.711', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '6.88', 'spread': '5.214', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '6.95', 'spread': '5.202', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'SAF population used for analysis.', 'unitOfMeasure': 'mm^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Best Corrected Visual Acuity (BCVA)', 'classes': [{'categories': [{'measurements': [{'value': '54.0', 'spread': '13.43', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '55.2', 'spread': '13.15', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '55.5', 'spread': '13.12', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '55.7', 'spread': '12.84', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '55.1', 'spread': '13.14', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'SAF population used for analysis. BCVA assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) chart. For BCVA tested via the 4 meter ETDRS protocol, 83 letters or more would represent 20/20 vision or better which would be considered an excellent outcome. Although, the ETDRS charts include 100 letters as the maximum possible score. The worst outcome is 0 letters read.', 'unitOfMeasure': 'letters read', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1217}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'dispFirstSubmitDate': '2011-01-05', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-20', 'studyFirstSubmitDate': '2007-07-31', 'dispFirstSubmitQcDate': '2011-01-05', 'resultsFirstSubmitDate': '2011-12-16', 'studyFirstSubmitQcDate': '2007-07-31', 'dispFirstPostDateStruct': {'date': '2011-01-10', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-12-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-13', 'studyFirstPostDateStruct': {'date': '2007-08-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)', 'timeFrame': 'Baseline and at week 52', 'description': 'Defined "maintenance of vision" as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF', 'timeFrame': 'Baseline and at week 52', 'description': 'Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.'}, {'measure': 'Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF.', 'timeFrame': 'Baseline and at week 52', 'description': 'Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.'}, {'measure': 'Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF', 'timeFrame': 'Baseline and at Week 52', 'description': 'The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.'}, {'measure': 'Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF)', 'timeFrame': 'Baseline and at week 52', 'description': 'CNV area values measured in square millimeters (mm\\^2); lower values represent better outcomes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '32374423', 'type': 'DERIVED', 'citation': 'Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.'}, {'pmid': '31826853', 'type': 'DERIVED', 'citation': 'Moshfeghi DM, Thompson D, Saroj N. Changes in neovascular activity following fixed dosing with an anti-vascular endothelial growth factor agent over 52 weeks in the phase III VIEW 1 and VIEW 2 studies. Br J Ophthalmol. 2020 Sep;104(9):1223-1227. doi: 10.1136/bjophthalmol-2019-315021. Epub 2019 Dec 11.'}, {'pmid': '25439429', 'type': 'DERIVED', 'citation': 'Yuzawa M, Fujita K, Wittrup-Jensen KU, Norenberg C, Zeitz O, Adachi K, Wang EC, Heier J, Kaiser P, Chong V, Korobelnik JF. Improvement in vision-related function with intravitreal aflibercept: data from phase 3 studies in wet age-related macular degeneration. Ophthalmology. 2015 Mar;122(3):571-8. doi: 10.1016/j.ophtha.2014.09.024. Epub 2014 Nov 6.'}]}, 'descriptionModule': {'briefSummary': 'This study is a phase 3, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in the US and Canada.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed Informed Consent.\n2. Men and women ≥ 50 years of age.\n3. Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.\n4. Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) of: letter score of 73 to 25 (20/40 to 20/320) in the study eye at 4 meters.\n5. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.\n6. Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member. See Appendix J.4) understand and willing to sign the informed consent form.\n\nKey\n\nExclusion Criteria:\n\n1. Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins.\n2. Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins.\n3. Any prior treatment with anti-VEGF agents in the study eye.\n4. Total lesion size \\> 12 disc areas (30.5 mm\\^2, including blood, scars and neovascularization) as assessed by FA in the study eye.\n5. Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood is under the fovea, then the fovea must be surrounded 270 degrees by visible CNV.)\n6. Scar or fibrosis, making up \\> 50% of total lesion in the study eye.\n7. Scar, fibrosis, or atrophy involving the center of the fovea.\n8. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.\n9. History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.\n10. Presence of other causes of CNV in the study eye.\n11. History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina,other than AMD, in either eye.\n12. Prior vitrectomy in the study eye.\n13. History of retinal detachment or treatment or surgery for retinal detachment in the study eye.\n14. Any history of macular hole of stage 2 and above in the study eye.\n15. Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as its unlikely to interfere with the injection.'}, 'identificationModule': {'nctId': 'NCT00509795', 'acronym': 'VIEW1', 'briefTitle': 'Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'VGFT-OD-0605'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ranibizumab 0.5mg Q4', 'interventionNames': ['Biological: ranibizumab']}, {'type': 'EXPERIMENTAL', 'label': 'aflibercept injection 2.0mg Q4', 'interventionNames': ['Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)']}, {'type': 'EXPERIMENTAL', 'label': 'aflibercept injection 0.5mg Q4', 'interventionNames': ['Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)']}, {'type': 'EXPERIMENTAL', 'label': 'aflibercept injection 2.0mg Q8', 'interventionNames': ['Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)']}], 'interventions': [{'name': 'ranibizumab', 'type': 'BIOLOGICAL', 'otherNames': ['Lucentis'], 'description': 'Participants received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.', 'armGroupLabels': ['ranibizumab 0.5mg Q4']}, {'name': 'aflibercept injection (VEGF Trap-Eye, BAY86-5321)', 'type': 'BIOLOGICAL', 'otherNames': ['VEGF Trap-Eye', 'BAY86-5321'], 'description': 'Participants received a 2.0mg dose of aflibercept injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.', 'armGroupLabels': ['aflibercept injection 2.0mg Q4']}, {'name': 'aflibercept injection (VEGF Trap-Eye, BAY86-5321)', 'type': 'BIOLOGICAL', 'otherNames': ['VEGF Trap-Eye', 'BAY86-5321'], 'description': 'Participants received a 0.5mg dose of aflibercept injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.', 'armGroupLabels': ['aflibercept injection 0.5mg Q4']}, {'name': 'aflibercept injection (VEGF Trap-Eye, BAY86-5321)', 'type': 'BIOLOGICAL', 'otherNames': ['VEGF Trap-Eye', 'BAY86-5321'], 'description': 'Participants received a 2.0mg dose of aflibercept injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.', 'armGroupLabels': ['aflibercept injection 2.0mg Q8']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35223', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85014', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 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