Viewing Study NCT01584232

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Ignite Creation Date: 2025-12-24 @ 9:48 PM
Ignite Modification Date: 2026-01-01 @ 9:24 AM
Study NCT ID: NCT01584232
Status: COMPLETED
Last Update Posted: 2014-10-20
First Post: 2012-04-23
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555680', 'term': 'dulaglutide'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D001645', 'term': 'Biguanides'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'LY2189265 + OAM', 'description': 'LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).', 'otherNumAtRisk': 181, 'otherNumAffected': 133, 'seriousNumAtRisk': 181, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Insulin Glargine + OAM', 'description': 'Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).', 'otherNumAtRisk': 180, 'otherNumAffected': 111, 'seriousNumAtRisk': 180, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Age-related macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Asthenopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cystoid macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Eyelid ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 31, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastritis atrophic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastrointestinal motility disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 27, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Periodontal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Infusion site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Injection site dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Injection site hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oedema due to renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gallbladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hepatic calcification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hepatic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abscess oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bacterial diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vith nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Alcohol problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diabetic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Asteatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Eczema asteatotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Prurigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urticaria chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Percutaneous coronary intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hyperplastic cholecystopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Colon neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Liver carcinoma ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Spinal cord infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Viith nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2189265 + OAM', 'description': 'LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).'}, {'id': 'OG001', 'title': 'Insulin Glargine + OAM', 'description': 'Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.44', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.54', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '-0.41', 'pValueComment': 'P-value is from the pairwise comparison of LS means using a mixed effects model with repeated measurements (MMRM).', 'groupDescription': 'Approximately 360 participants were to be randomized in a 1:1 ratio to LY2189265 or insulin glargine (IG). Assuming no difference in HbA1c change from baseline at Week 26 between LY2189265 and IG, this sample size would provide approximately 90% power to confirm non-inferiority of LY2189265 to IG. This computation was based on a non-inferiority margin of 0.4% with a standard deviation of 1.1%, a 1-sided alpha level of 0.025, and an 11% dropout rate between randomization and Week 26.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'If the upper limit of the 95% Confidence Interval (CI) was \\<0.4%, then LY2189265 was declared non-inferior to insulin glargine. If the upper limit of the 95% CI was \\<0.0%, then LY2189265 was declared superior to insulin glargine.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks', 'description': 'Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\\<25 or \\>=25 kilograms per meter squared \\[kg/m\\^2\\]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable HbA1c data. Only pre-rescue measurements were used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2189265 + OAM', 'description': 'LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).'}, {'id': 'OG001', 'title': 'Insulin Glargine + OAM', 'description': 'Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).'}], 'classes': [{'title': 'HbA1c <=6.5%', 'categories': [{'measurements': [{'value': '51.1', 'groupId': 'OG000'}, {'value': '24.0', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <7%', 'categories': [{'measurements': [{'value': '71.3', 'groupId': 'OG000'}, {'value': '45.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Treatment comparison for HbA1c \\<=6.5%.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Treatment comparison for HbA1c \\<7%.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 26 weeks', 'description': 'The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a longitudinal logistic regression model with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\\<25 or \\>=25 kilograms per meter squared \\[kg/m\\^2\\]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2189265 + OAM', 'description': 'LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).'}, {'id': 'OG001', 'title': 'Insulin Glargine + OAM', 'description': 'Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).'}], 'classes': [{'categories': [{'measurements': [{'value': '-34.3', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-37.8', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.183', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '8.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks', 'description': 'Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\\<25 or \\>=25 kilograms per meter squared \\[kg/m\\^2\\]) as fixed effects, baseline FBG as a covariate, and participant as a random effect.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable fasting blood glucose data. Only pre-rescue measurements were used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2189265 + OAM', 'description': 'LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).'}, {'id': 'OG001', 'title': 'Insulin Glargine + OAM', 'description': 'Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).'}], 'classes': [{'title': 'Pre-morning meal (n=178, 179)', 'categories': [{'measurements': [{'value': '-33.49', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '-38.66', 'spread': '1.64', 'groupId': 'OG001'}]}]}, {'title': '2 hours post-morning meal (n=178, 179)', 'categories': [{'measurements': [{'value': '-49.54', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '-36.14', 'spread': '3.31', 'groupId': 'OG001'}]}]}, {'title': 'Pre-midday meal (n=178, 179)', 'categories': [{'measurements': [{'value': '-36.16', 'spread': '2.68', 'groupId': 'OG000'}, {'value': '-27.94', 'spread': '2.66', 'groupId': 'OG001'}]}]}, {'title': '2 hours post-midday meal (n=178, 179)', 'categories': [{'measurements': [{'value': '-43.51', 'spread': '3.27', 'groupId': 'OG000'}, {'value': '-20.30', 'spread': '3.25', 'groupId': 'OG001'}]}]}, {'title': 'Pre-evening meal (n=178, 179)', 'categories': [{'measurements': [{'value': '-31.14', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '-17.50', 'spread': '2.75', 'groupId': 'OG001'}]}]}, {'title': '2 hours post-evening meal (n=177, 178)', 'categories': [{'measurements': [{'value': '-46.68', 'spread': '3.05', 'groupId': 'OG000'}, {'value': '-15.55', 'spread': '3.03', 'groupId': 'OG001'}]}]}, {'title': 'Bedtime (n=177, 172)', 'categories': [{'measurements': [{'value': '-41.53', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '-17.79', 'spread': '2.96', 'groupId': 'OG001'}]}]}, {'title': 'Second pre-morning meal (n=178, 179)', 'categories': [{'measurements': [{'value': '-30.81', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '-37.02', 'spread': '1.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.16', 'ciLowerLimit': '0.76', 'ciUpperLimit': '9.56', 'pValueComment': 'Treatment comparison for pre-morning meal.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.40', 'ciLowerLimit': '-22.28', 'ciUpperLimit': '-4.52', 'pValueComment': 'Treatment comparison for 2 hours post-morning meal.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.22', 'ciLowerLimit': '-15.37', 'ciUpperLimit': '-1.06', 'pValueComment': 'Treatment comparison for pre-midday meal.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.22', 'ciLowerLimit': '-31.92', 'ciUpperLimit': '-14.51', 'pValueComment': 'Treatment comparison for 2 hours post-midday meal.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.63', 'ciLowerLimit': '-21.03', 'ciUpperLimit': '-6.24', 'pValueComment': 'Treatment comparison for pre-evening meal.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-31.13', 'ciLowerLimit': '-39.26', 'ciUpperLimit': '-23.00', 'pValueComment': 'Treatment comparison for 2 hours post-evening meal.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.73', 'ciLowerLimit': '-31.68', 'ciUpperLimit': '-15.79', 'pValueComment': 'Treatment comparison for bedtime.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.21', 'ciLowerLimit': '1.92', 'ciUpperLimit': '10.50', 'pValueComment': 'Treatment comparison for second pre-morning meal.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Up to 26 weeks', 'description': 'Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal, at bedtime, and before breakfast the next morning (second pre-morning meal). Least squares (LS) means were calculated using analysis of covariance (ANCOVA) model with treatment, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\\<25 or \\>=25 kilograms per meter squared \\[kg/m\\^2\\]) as fixed effects and baseline SMBG as a covariate.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable SMBG data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at 26 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2189265 + OAM', 'description': 'LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).'}, {'id': 'OG001', 'title': 'Insulin Glargine + OAM', 'description': 'Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '0.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.42', 'ciLowerLimit': '-1.89', 'ciUpperLimit': '-0.94', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks', 'description': 'Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\\<25 or \\>=25 kilograms per meter squared \\[kg/m\\^2\\]) as fixed effects, baseline body weight as a covariate, and participant as a random effect.', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable body weight data. Only pre-rescue measurements were used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Hypoglycemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2189265 + OAM', 'description': 'LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).'}, {'id': 'OG001', 'title': 'Insulin Glargine + OAM', 'description': 'Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).'}], 'classes': [{'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000'}, {'value': '47.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 26 Weeks', 'description': 'The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least one hypoglycemic episode over the 26-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine. Only pre-rescue data was used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LY2189265 + OAM', 'description': 'LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).'}, {'id': 'FG001', 'title': 'Insulin Glargine + OAM', 'description': 'Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '180'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '180'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '177'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '361', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LY2189265 + OAM', 'description': 'LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).'}, {'id': 'BG001', 'title': 'Insulin Glargine + OAM', 'description': 'Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.52', 'spread': '10.48', 'groupId': 'BG000'}, {'value': '56.14', 'spread': '11.33', 'groupId': 'BG001'}, {'value': '56.83', 'spread': '10.92', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '361', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '361', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All randomized participants who received at least 1 dose of LY2189265 or insulin glargine.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 361}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'dispFirstSubmitDate': '2013-09-27', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-14', 'studyFirstSubmitDate': '2012-04-23', 'dispFirstSubmitQcDate': '2013-09-27', 'resultsFirstSubmitDate': '2014-10-03', 'studyFirstSubmitQcDate': '2012-04-23', 'dispFirstPostDateStruct': {'date': '2013-10-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-14', 'studyFirstPostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks', 'timeFrame': 'Baseline, 26 weeks', 'description': 'Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\\<25 or \\>=25 kilograms per meter squared \\[kg/m\\^2\\]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks', 'timeFrame': 'Up to 26 weeks', 'description': 'The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a longitudinal logistic regression model with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\\<25 or \\>=25 kilograms per meter squared \\[kg/m\\^2\\]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks', 'timeFrame': 'Baseline, 26 weeks', 'description': 'Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\\<25 or \\>=25 kilograms per meter squared \\[kg/m\\^2\\]) as fixed effects, baseline FBG as a covariate, and participant as a random effect.'}, {'measure': 'Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks', 'timeFrame': 'Baseline, Up to 26 weeks', 'description': 'Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal, at bedtime, and before breakfast the next morning (second pre-morning meal). Least squares (LS) means were calculated using analysis of covariance (ANCOVA) model with treatment, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\\<25 or \\>=25 kilograms per meter squared \\[kg/m\\^2\\]) as fixed effects and baseline SMBG as a covariate.'}, {'measure': 'Change From Baseline in Body Weight at 26 Weeks', 'timeFrame': 'Baseline, 26 weeks', 'description': 'Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\\<25 or \\>=25 kilograms per meter squared \\[kg/m\\^2\\]) as fixed effects, baseline body weight as a covariate, and participant as a random effect.'}, {'measure': 'Percentage of Participants With Hypoglycemic Episodes', 'timeFrame': 'Baseline through 26 Weeks', 'description': 'The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least one hypoglycemic episode over the 26-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glucagon-like peptide-1 (GLP-1)'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '28606095', 'type': 'DERIVED', 'citation': 'Suzuki S, Oura T, Takeuchi M, Boye KS. Evaluation of the impact of once weekly dulaglutide on patient-reported outcomes in Japanese patients with type 2 diabetes: comparisons with liraglutide, insulin glargine, and placebo in two randomized studies. Health Qual Life Outcomes. 2017 Jun 12;15(1):123. doi: 10.1186/s12955-017-0696-7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 (dulaglutide) in participants with type 2 diabetes mellitus taking an oral antihyperglycemic medication (OAM).', 'detailedDescription': 'Rescue therapy (defined as alternative antihyperglycemic medication use or dose modification of oral antihyperglycemic medication \\[OAM\\]) may have been initiated during the planned treatment period if the participant discontinued study drug or met prespecified thresholds for severe, persistent hyperglycemia. Efficacy data, as well as data for hypoglycemic episodes from participants who permanently discontinued study treatment but switched to another diabetes medication and remained in the study, were censored from the point of initiating new treatment onwards.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who have had a diagnosis of type 2 diabetes mellitus for at least 6 months before screening\n* Participants who have been taking sulfonylurea (glibenclamide, gliclazide, or glimepiride) and/or biguanide (metformin or buformin). The dose of the drug(s) during the 8 weeks before screening must be stable\n* Participants who have a qualifying glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% at screening\n* Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m\\^2)\n\nExclusion Criteria:\n\n* Participants who have a diagnosis of type 1 diabetes\n* Participants who have previously been treated with any other glucagon-like peptide 1 (GLP-1) analog\n* Participants who have received therapy with an alpha-glucosidase inhibitor (a-GI), thiazolidinedione (TZD), glinide, or dipeptidyl peptidase-IV (DPP-IV) inhibitor within 3 months before screening\n* Participants who have been currently taking insulin or have had previous insulin treatment within 3 months before screening\n* Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis, or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥ 3 times the upper limit of the reference range and/or a serum lipase concentration ≥ 2 times the upper limit of the reference range, as determined by the central laboratory at screening\n* Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC)'}, 'identificationModule': {'nctId': 'NCT01584232', 'briefTitle': 'A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3 Study of LY2189265 Compared to Insulin Glargine in Patients With Type 2 Diabetes Mellitus on a Sulfonylurea and/or Biguanide', 'orgStudyIdInfo': {'id': '14359'}, 'secondaryIdInfos': [{'id': 'H9X-JE-GBDY', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY2189265 + OAM', 'description': 'LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).', 'interventionNames': ['Drug: LY2189265', 'Drug: Sulfonylureas (SU)', 'Drug: Biguanide (BG)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin glargine + OAM', 'description': 'Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).', 'interventionNames': ['Drug: Insulin glargine', 'Drug: Sulfonylureas (SU)', 'Drug: Biguanide (BG)']}], 'interventions': [{'name': 'LY2189265', 'type': 'DRUG', 'otherNames': ['Dulaglutide'], 'armGroupLabels': ['LY2189265 + OAM']}, {'name': 'Insulin glargine', 'type': 'DRUG', 'armGroupLabels': ['Insulin glargine + OAM']}, {'name': 'Sulfonylureas (SU)', 'type': 'DRUG', 'armGroupLabels': ['Insulin glargine + OAM', 'LY2189265 + OAM']}, {'name': 'Biguanide (BG)', 'type': 'DRUG', 'armGroupLabels': ['Insulin glargine + OAM', 'LY2189265 + OAM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '448-0852', 'city': 'Aichi', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': '286-0048', 'city': 'Chiba', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '790-0024', 'city': 'Ehime', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '819-0168', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '0530018', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '8910401', 'city': 'Kagoshima', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '247-0055', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '860-0811', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '606-8397', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '385-0022', 'city': 'Nagano', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'zip': '857-1195', 'city': 'Nagasaki', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '598-0048', 'city': 'Osaka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '8700039', 'city': 'Ōita', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'zip': '103-0028', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '754-0002', 'city': 'Yamaguchi', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.18333, 'lon': 131.46667}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}