Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
Study NCT ID:
NCT01358266
Status:
COMPLETED
Last Update Posted:
2019-07-16
First Post:
2011-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Assessing Double-masked Uveitis Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Dominican Republic', 'Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D014605', 'term': 'Uveitis'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@santen.com', 'phone': '+1-415-268-9100', 'title': 'Clinical Operations', 'organization': 'Santen Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months.', 'description': 'Any subject with multiple AEs of one system organ class is counted only once for that class.\n\nSubjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2\n\n1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.', 'eventGroups': [{'id': 'EG000', 'title': 'DE-109 44 µg - Double Masked', 'description': 'Double Masked Phase Low Dose 44 µg', 'otherNumAtRisk': 207, 'deathsNumAtRisk': 207, 'otherNumAffected': 165, 'seriousNumAtRisk': 207, 'deathsNumAffected': 1, 'seriousNumAffected': 41}, {'id': 'EG001', 'title': 'DE-109 440 µg - Double Masked', 'description': 'Double Masked Phase Medium Dose 440 µg', 'otherNumAtRisk': 205, 'deathsNumAtRisk': 205, 'otherNumAffected': 166, 'seriousNumAtRisk': 205, 'deathsNumAffected': 0, 'seriousNumAffected': 45}, {'id': 'EG002', 'title': 'DE-109 880 µg - Double Masked', 'description': 'Double Masked Phase High Dose 880 µg', 'otherNumAtRisk': 178, 'deathsNumAtRisk': 178, 'otherNumAffected': 148, 'seriousNumAtRisk': 178, 'deathsNumAffected': 0, 'seriousNumAffected': 38}, {'id': 'EG003', 'title': 'DE-109 880 µg - Open-Label', 'description': 'Open-label Phase High Dose 880 µg', 'otherNumAtRisk': 321, 'deathsNumAtRisk': 321, 'otherNumAffected': 210, 'seriousNumAtRisk': 321, 'deathsNumAffected': 0, 'seriousNumAffected': 59}], 'otherEvents': [{'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 41, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 46, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 51, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 48, 'numAffected': 31}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 42, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 32, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 33, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 33, 'numAffected': 24}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 27, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intermediate uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 33, 'numAffected': 32}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cystoid macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Choroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cataract subcapsular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 50, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 62, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 64, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 62, 'numAffected': 44}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vitreous opacities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Cerebrovascular accident', 'notes': '1 subject 44 µg dose group died • a 63-year-old male who suffered a stroke on Day 54 (11 Sep 2012) of study participation.This subject died on Study Day 55 (12 Sep 2012). This SAE was reported as severe, and not related to the study medication.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Choroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Non-infectious endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vitritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cystoid macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Eye inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intermediate uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Optic atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Optic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Anterior chamber inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Choroidal neovascularisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Corneal deposits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Corneal epithelium defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Corneal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Eye haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ocular hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ocular vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Open angle glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Retinal infiltrates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Retinal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Eye infection toxoplasmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Keratitis herpetic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fibrin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intraocular pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Medication residue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cataract traumatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Corneal abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Central nervous system lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cataract subcapsular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Optic Neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tibia Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DE-109 44 µg', 'description': 'Low Dose DE-109 44 µg'}, {'id': 'OG001', 'title': 'DE-109 440 µg', 'description': 'Medium Dose DE-109 440 µg'}, {'id': 'OG002', 'title': 'DE-109 880 µg', 'description': 'High Dose DE-109 880 µg'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day1 (Baseline) and Month 5 (Day150)', 'description': 'At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification\n\nVitreous Haze Scale Description VH score 0 = No inflammation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'VH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DE-109 44 µg', 'description': 'Low Dose DE-109 44 µg'}, {'id': 'OG001', 'title': 'DE-109 440 µg', 'description': 'Medium Dose DE-109 440 µg'}, {'id': 'OG002', 'title': 'DE-109 880 µg', 'description': 'High Dose DE-109 880 µg'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day1/Baseline and Day150/Month 5', 'description': 'At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)\n\n1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+\n2. Moderate blurring of the optic nerve head\n3. Marked blurring of the optic nerve head\n4. Optic Nerve head not visible', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DE-109 44 µg', 'description': 'Low Dose DE-109 44 µg'}, {'id': 'OG001', 'title': 'DE-109 440 µg', 'description': 'Medium Dose DE-109 440 µg'}, {'id': 'OG002', 'title': 'DE-109 880 µg', 'description': 'High Dose DE-109 880 µg'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day1/Baseline and Day150/Month 5', 'description': 'At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0.5+=Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'VH 0 Response at Month 6: Having a VH Score of 0 at Month 6 (Modified SUN Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DE-109 44 µg', 'description': 'Low Dose DE-109 44 µg'}, {'id': 'OG001', 'title': 'DE-109 440 µg', 'description': 'Medium Dose DE-109 440 µg'}, {'id': 'OG002', 'title': 'DE-109 880 µg', 'description': 'High Dose DE-109 880 µg'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day1/Baseline and Day180/Month 6', 'description': 'At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification\n\nVitreous Haze Scale Description VH score 0 = No inflammation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'VH 0 or 2-unit Response at Month 6: Having a VH Score of 0 or a Decrease (Improvement) of at Least 2 Units From Baseline in VH Score at Month 6 (Modified SUN Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DE-109 44 µg', 'description': 'Low Dose DE-109 44 µg'}, {'id': 'OG001', 'title': 'DE-109 440 µg', 'description': 'Medium Dose DE-109 440 µg'}, {'id': 'OG002', 'title': 'DE-109 880 µg', 'description': 'High Dose DE-109 880 µg'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day1/Baseline and Day180/Month 6', 'description': 'At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)\n\n1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+\n2. Moderate blurring of the optic nerve head\n3. Marked blurring of the optic nerve head\n4. Optic Nerve head not visible', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'VH 0 or 0.5+ Response at Month 6: Having a VH Score of 0 or 0.5+ at Month 6 (Modified SUNscale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DE-109 44 µg', 'description': 'Low Dose DE-109 44 µg'}, {'id': 'OG001', 'title': 'DE-109 440 µg', 'description': 'Medium Dose DE-109 440 µg'}, {'id': 'OG002', 'title': 'DE-109 880 µg', 'description': 'High Dose DE-109 880 µg'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day1/Baseline and Day180/Month 6', 'description': 'At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)\n\n1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+\n2. Moderate blurring of the optic nerve head\n3. Marked blurring of the optic nerve head\n4. Optic Nerve head not visible', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DE-109 44 μg', 'description': 'SAKURA Study 1 \\& Study 2 (Amendment #2) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4 Double-Masked PRN Treatment Period May receive up to 3 injections PRN from Month 6 through Month 10 SAKURA Study 1 \\& Study 2 (Amendments #3 and #4) Injection on Day 1, Month 2, Month 4 SAKURA Study 2 (Amendment #5) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4'}, {'id': 'FG001', 'title': 'DE-109 440 μg', 'description': 'SAKURA Study 1 \\& Study 2 (Amendment #2) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4 Double-Masked PRN Treatment Period May receive up to 3 injections PRN from Month 6 through Month 10 SAKURA Study 1 \\& Study 2 (Amendments #3 and #4) Injection on Day 1, Month 2, Month 4 SAKURA Study 2 (Amendment #5) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4'}, {'id': 'FG002', 'title': 'DE-109 880 μg', 'description': 'SAKURA Study 1 \\& Study 2 (Amendment #2) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4 Double-Masked PRN Treatment Period May receive up to 3 injections PRN from Month 6 through Month 10 SAKURA Study 1 \\& Study 2 (Amendments #3 and #4) Injection on Day 1, Month 2, Month 4\n\nOpen-Label Treatment Period Injection on Month 6, Month 8, Month 10 Open-Label Re-Treatment Period May receive up to 6 injections PRN through Month 22 SAKURA Study 2 (Amendment #5) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4'}], 'periods': [{'title': 'Double-Masked Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '208'}, {'groupId': 'FG002', 'numSubjects': '176'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '162'}, {'groupId': 'FG002', 'numSubjects': '137'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '39'}]}]}, {'title': 'Open-Label Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '102'}, {'groupId': 'FG002', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '70'}]}]}], 'preAssignmentDetails': 'Subjects who entered open-label period are defined as subjects who received at least one open-label injection during the open-label treatment period (Month 6 to Month 12, exclude Amendment 2 subjects), or those who had entered the open-label retreatment period (Month 12 to Month 24) with or without any PRN injections.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}, {'value': '592', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'DE-109 44 µg', 'description': 'Double Masked Phase Low Dose 44 µg Open Label Phase High Dose 880 µg'}, {'id': 'BG001', 'title': 'DE-109 440 µg', 'description': 'Double Masked Phase Medium Dose 440 µg Open Label Phase High Dose 880 µg'}, {'id': 'BG002', 'title': 'DE-109 880 µg', 'description': 'Double Masked Phase High Dose 880 µg Open Label Phase High Dose 880 µg'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}, {'value': '532', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '343', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '225', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '271', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Colombia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '186', 'groupId': 'BG003'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '199', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Peru', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, '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': 592}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-21', 'studyFirstSubmitDate': '2011-05-19', 'resultsFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2011-05-20', 'lastUpdatePostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-21', 'studyFirstPostDateStruct': {'date': '2011-05-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'VH 0 Response at Month 6: Having a VH Score of 0 at Month 6 (Modified SUN Scale)', 'timeFrame': 'Day1/Baseline and Day180/Month 6', 'description': 'At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification\n\nVitreous Haze Scale Description VH score 0 = No inflammation'}, {'measure': 'VH 0 or 2-unit Response at Month 6: Having a VH Score of 0 or a Decrease (Improvement) of at Least 2 Units From Baseline in VH Score at Month 6 (Modified SUN Scale)', 'timeFrame': 'Day1/Baseline and Day180/Month 6', 'description': 'At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)\n\n1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+\n2. Moderate blurring of the optic nerve head\n3. Marked blurring of the optic nerve head\n4. Optic Nerve head not visible'}, {'measure': 'VH 0 or 0.5+ Response at Month 6: Having a VH Score of 0 or 0.5+ at Month 6 (Modified SUNscale)', 'timeFrame': 'Day1/Baseline and Day180/Month 6', 'description': 'At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)\n\n1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+\n2. Moderate blurring of the optic nerve head\n3. Marked blurring of the optic nerve head\n4. Optic Nerve head not visible'}], 'primaryOutcomes': [{'measure': 'The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5', 'timeFrame': 'Day1 (Baseline) and Month 5 (Day150)', 'description': 'At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification\n\nVitreous Haze Scale Description VH score 0 = No inflammation'}], 'secondaryOutcomes': [{'measure': 'VH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale)', 'timeFrame': 'Day1/Baseline and Day150/Month 5', 'description': 'At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)\n\n1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+\n2. Moderate blurring of the optic nerve head\n3. Marked blurring of the optic nerve head\n4. Optic Nerve head not visible'}, {'measure': 'VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)', 'timeFrame': 'Day1/Baseline and Day150/Month 5', 'description': 'At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0.5+=Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Uveitis; Posterior, Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of active uveitis\n* 18 years of age or older\n* Sign informed consent\n* Meet best corrected ETDRS visual acuity\n\nExclusion Criteria:\n\n* Uveitis of infectious etiology\n* Suspected/confirmed central nervous system or ocular lymphoma\n* Primary diagnosis of anterior uveitis\n* Uncontrolled glaucoma\n* Use of topical oculary medication\n* Implanted device\n* Significant ocular disease\n* Lens/media opacities or obscured ocular media\n* Intraocular surgery or treatments\n* Capsulotomy\n* Ocular or periocular infection\n* Pupillary dilation\n* History of herpetic infection\n* Toxoplasmosis or toxoplasmosis scar\n* Ocular malignancy\n* Allergy or hypersensitivity to study drug\n* Participation in other uveitis trial within 30 days\n* Monoclonal antibody treatment or biologic therapy\n* Any systemic condition/infection\n* Immunosuppressive therapy or immunocompromised\n* Malignancy remission\n* Females who are pregnant or lactating and females not using adequate contraceptives'}, 'identificationModule': {'nctId': 'NCT01358266', 'acronym': 'SAKURA', 'briefTitle': 'Study Assessing Double-masked Uveitis Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santen Inc.'}, 'officialTitle': 'A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the 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