Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-30 @ 12:13 AM
Study NCT ID:
NCT01191268
Status:
COMPLETED
Last Update Posted:
2014-10-08
First Post:
2010-08-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Africa']}, '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': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'C555680', 'term': 'dulaglutide'}, {'id': 'D061268', 'term': 'Insulin Lispro'}], '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': 'D061266', 'term': 'Insulin, Short-Acting'}]}}, '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': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks', 'otherNumAtRisk': 295, 'otherNumAffected': 219, 'seriousNumAtRisk': 295, 'seriousNumAffected': 27}, {'id': 'EG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks', 'otherNumAtRisk': 293, 'otherNumAffected': 232, 'seriousNumAtRisk': 293, 'seriousNumAffected': 46}, {'id': 'EG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks', 'otherNumAtRisk': 296, 'otherNumAffected': 203, 'seriousNumAtRisk': 296, 'seriousNumAffected': 53}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 62, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 67, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 115, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 74, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 46, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 49, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Common cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 37, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 33, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Flu syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 27, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 43, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 18, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyslipidemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 21, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Shoulder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hemorrhagic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Iron deficiency anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Atrioventricular block third degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardiac pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardiogenic shock', 'notes': 'Event resulted in death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Coronary artery insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Coronary atherosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Coronary insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Decompensated heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fibrillation ventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Heart block third degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Infarct myocardial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Non st segment elevation myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Non stemi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Non-sustained ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Unstable angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ventricular fibrillation', 'notes': 'Event resulted in death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Retinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chronic diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis noninfectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hemorrhoidal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lower gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Paralytic ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chest pain exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Generalized edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Multiple organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ancylostomiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cellulitis of foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cellulitis of leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Epiglottitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gangrenous appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis norovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hookworm infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Infected bites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Infected toe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pleurisy viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia', 'notes': 'One event resulted in one death in 0.75 mg LY2189265 arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sepsis', 'notes': 'One event resulted in one death in 1.5 mg LY2189265 arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Staphylococcus aureus septicemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Supraglottitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Falling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fractured ribs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fractured sternum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Knee fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Leg injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lumbar vertebral fracture l1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Meniscus tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Quadriceps tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sternal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Suture related complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Torn muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 17, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 16, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 20, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoglycemic episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cervical pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lumbar pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Osteoarthritis aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rotator cuff tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gallbladder adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gallbladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rectal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Amyotrophic lateral sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Carotid artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoglycaemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoglycemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ischemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lumboischialgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Orthostatic collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Palsy bells', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Transient cerebral ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Unilateral carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Viith nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Mental confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Unilateral renal artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ureteral calculus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ureteric calculus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Premenopausal menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Atherosclerosis generalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.64', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-1.59', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-1.41', 'spread': '0.07', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '-0.07', 'pValueComment': 'Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.', 'groupDescription': 'The study was designed to enroll 837 randomized participants (279 per treatment arm) with 90% power to detect non-inferiority of 1.5 mg LY2189265 versus Insulin Glargine on HbA1c change from baseline at the 26-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 1-sided alpha of 0.025 assuming no true difference between treatments. This corresponds to 248 participants per arm, with an assumed drop-out rate of 11%.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'If the upper limit of the 95% Confidence Interval (CI) of 1.5 mg LY2189265 versus Insulin Glargine was below 0.4%, 1.5 mg LY2189265 was declared non-inferior to Insulin Glargine.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '-0.02', 'pValueComment': 'Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'If the 1-sided adjusted p-value was below 0.025, then 0.75 mg LY2189265 was declared non-inferior to Insulin Glargine.'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '-0.07', 'pValueComment': 'Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.', 'groupDescription': 'Superiority analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.015', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '-0.02', 'pValueComment': 'Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.', 'groupDescription': 'Superiority analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks', 'description': 'Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Error', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.48', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-1.42', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '-1.23', 'spread': '0.08', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '-0.07', 'pValueComment': 'Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'If the upper limit of the 95% Confidence Interval (CI) of 1.5 mg LY2189265 versus Insulin Glargine was below 0.4%, 1.5 mg LY2189265 was declared non-inferior to Insulin Glargine.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '-0.02', 'pValueComment': 'Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'If the 1-sided adjusted p-value was below 0.025, then 0.75 mg LY2189265 was declared non-inferior to Insulin Glargine.'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '-0.07', 'pValueComment': 'Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.', 'groupDescription': 'Superiority analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.014', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '-0.02', 'pValueComment': 'Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.', 'groupDescription': 'Superiority analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 52 weeks', 'description': 'Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Error', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': 'HbA1c less than 7.0%, 26 weeks', 'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000'}, {'value': '69.0', 'groupId': 'OG001'}, {'value': '56.8', 'groupId': 'OG002'}]}]}, {'title': 'HbA1c less than 7.0%, 52 weeks', 'categories': [{'measurements': [{'value': '58.5', 'groupId': 'OG000'}, {'value': '56.3', 'groupId': 'OG001'}, {'value': '49.3', 'groupId': 'OG002'}]}]}, {'title': 'HbA1c less than or equal to 6.5%, 26 weeks', 'categories': [{'measurements': [{'value': '48.0', 'groupId': 'OG000'}, {'value': '43.0', 'groupId': 'OG001'}, {'value': '37.5', 'groupId': 'OG002'}]}]}, {'title': 'HbA1c less than or equal to 6.5%, 52 weeks', 'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000'}, {'value': '34.7', 'groupId': 'OG001'}, {'value': '30.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Treatment comparison for HbA1c less than 7.0% at 26 weeks.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.010', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'Treatment comparison for HbA1c less than 7.0% at 26 weeks.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.027', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.384', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Treatment comparison for HbA1c less than 7% at 52 weeks.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.250', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'Treatment comparison for HbA1c less than 7% at 52 weeks.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.272', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.623', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks and 52 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 repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model.', 'unitOfMeasure': 'percentage of participants', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': '26 weeks', 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000'}, {'value': '54.5', 'groupId': 'OG001'}, {'value': '28.2', 'groupId': 'OG002'}]}]}, {'title': '52 weeks', 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000'}, {'value': '44.0', 'groupId': 'OG001'}, {'value': '26.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Treatment comparison at 26 weeks.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'Treatment comparison at 26 weeks.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Treatment comparison at 52 weeks.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'Treatment comparison at 52 weeks.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'The percentage of participants achieving HbA1c less than 7.0% without nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking) or severe (episodes requiring the assistance of another person to actively administer resuscitative actions) hypoglycemia was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model.', 'unitOfMeasure': 'percentage of participants', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': 'Pre-morning meal, 26 weeks (n=228, 231, 232)', 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-2.01', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'Post-morning meal, 26 weeks (n=220, 227, 229)', 'categories': [{'measurements': [{'value': '-3.70', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-3.29', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '-4.03', 'spread': '0.18', 'groupId': 'OG002'}]}]}, {'title': 'Pre-midday meal, 26 weeks (n=227, 231, 233)', 'categories': [{'measurements': [{'value': '-2.80', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-2.38', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '-2.65', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Post-midday meal, 26 weeks (n=219, 227, 228)', 'categories': [{'measurements': [{'value': '-4.51', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-4.53', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-3.70', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Pre-evening meal, 26 weeks (n=226, 231, 232)', 'categories': [{'measurements': [{'value': '-3.24', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-3.06', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '-2.74', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Post-evening meal, 26 weeks (n=220, 228, 227)', 'categories': [{'measurements': [{'value': '-4.61', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-4.54', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-3.90', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Bedtime, 26 weeks (n=220, 221, 226)', 'categories': [{'measurements': [{'value': '-4.00', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-3.89', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-3.40', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'After bedtime, 26 weeks (n=208, 216, 208)', 'categories': [{'measurements': [{'value': '-1.48', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.50', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-1.96', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Daily Mean, 26 weeks (n=202, 206, 199)', 'categories': [{'measurements': [{'value': '-3.17', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-2.97', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '-3.10', 'spread': '0.12', 'groupId': 'OG002'}]}]}, {'title': 'Pre-morning meal, 52 weeks (n=207, 213, 218)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-2.02', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Post-morning meal, 52 weeks (n=200, 211, 211)', 'categories': [{'measurements': [{'value': '-3.38', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-3.23', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '-3.76', 'spread': '0.19', 'groupId': 'OG002'}]}]}, {'title': 'Pre-midday meal, 52 weeks (n=207, 213, 218)', 'categories': [{'measurements': [{'value': '-2.53', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-2.52', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-2.63', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'Post-midday meal, 52 weeks (n=202, 210, 212)', 'categories': [{'measurements': [{'value': '-4.33', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-4.29', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-3.83', 'spread': '0.18', 'groupId': 'OG002'}]}]}, {'title': 'Pre-evening meal, 52 weeks (n=207, 214, 217)', 'categories': [{'measurements': [{'value': '3.00', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-3.07', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '-2.67', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Post-evening meal, 52 weeks (n=200, 210, 212)', 'categories': [{'measurements': [{'value': '-4.22', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-4.54', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-3.71', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Bedtime, 52 weeks (n=195, 205, 213)', 'categories': [{'measurements': [{'value': '-3.62', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-3.96', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-3.27', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'After bedtime, 52 weeks (n=192, 192 197)', 'categories': [{'measurements': [{'value': '-1.17', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.36', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-1.80', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Daily Mean, 52 weeks (n=182, 185, 189)', 'categories': [{'measurements': [{'value': '-2.84', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-2.95', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '-2.97', 'spread': '0.12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.628', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.21', 'pValueComment': 'Treatment comparison of Daily Mean values at 26 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.368', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.41', 'pValueComment': 'Treatment comparison of Daily Mean values at 26 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.370', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.42', 'pValueComment': 'Treatment comparison of Daily Mean values at 52 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.879', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.30', 'pValueComment': 'Treatment comparison of Daily Mean values at 52 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'The self-monitored plasma glucose (SMPG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. The mean of the 8 time points (Daily Mean) was also calculated. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.', 'unitOfMeasure': 'millimoles per liter (mmol/L)]', 'dispersionType': 'Standard Error', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable SMPG data. Only pre-rescue measurements were used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}, {'value': '294', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': '26 weeks (n=253, 256, 255)', 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '-1.58', 'spread': '0.20', 'groupId': 'OG002'}]}]}, {'title': '52 weeks (n=237, 238, 246)', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '-1.01', 'spread': '0.22', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.79', 'pValueComment': 'Treatment comparison at 26 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.80', 'ciLowerLimit': '1.32', 'ciUpperLimit': '2.28', 'pValueComment': 'Treatment comparison at 26 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.64', 'pValueComment': 'Treatment comparison at 52 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.42', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.96', 'pValueComment': 'Treatment comparison at 52 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'Fasting serum glucose was measured by the central laboratory. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline fasting blood glucose as a covariate.', 'unitOfMeasure': 'millimoles per liter (mmol/L)', 'dispersionType': 'Standard Error', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable fasting blood glucose data. Only pre-rescue measurements were used.'}, {'type': 'SECONDARY', 'title': 'Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': 'TDI, Baseline', 'categories': [{'measurements': [{'value': '55.20', 'spread': '32.17', 'groupId': 'OG000'}, {'value': '59.11', 'spread': '38.12', 'groupId': 'OG001'}, {'value': '53.93', 'spread': '30.67', 'groupId': 'OG002'}]}]}, {'title': 'TDI, 26 weeks (n=244, 251, 254)', 'categories': [{'measurements': [{'value': '93.24', 'spread': '78.02', 'groupId': 'OG000'}, {'value': '96.69', 'spread': '62.13', 'groupId': 'OG001'}, {'value': '132.00', 'spread': '79.01', 'groupId': 'OG002'}]}]}, {'title': 'TDI, 52 weeks (n=224, 227, 238)', 'categories': [{'measurements': [{'value': '88.15', 'spread': '62.95', 'groupId': 'OG000'}, {'value': '95.00', 'spread': '67.62', 'groupId': 'OG001'}, {'value': '133.19', 'spread': '80.75', 'groupId': 'OG002'}]}]}, {'title': 'Insulin Lispro, 26 weeks (n=244, 251, 254)', 'categories': [{'measurements': [{'value': '93.24', 'spread': '78.02', 'groupId': 'OG000'}, {'value': '96.69', 'spread': '62.13', 'groupId': 'OG001'}, {'value': '67.79', 'spread': '44.59', 'groupId': 'OG002'}]}]}, {'title': 'Insulin Lispro, 52 weeks (n=224, 227, 238)', 'categories': [{'measurements': [{'value': '88.15', 'spread': '62.95', 'groupId': 'OG000'}, {'value': '95.00', 'spread': '67.62', 'groupId': 'OG001'}, {'value': '69.12', 'spread': '49.07', 'groupId': 'OG002'}]}]}, {'title': 'Insulin Glargine, 26 weeks (n=244, 251, 254)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Participants in this treatment arm were not exposed to Insulin Glargine.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Participants in this treatment arm were not exposed to Insulin Glargine.', 'groupId': 'OG001'}, {'value': '64.48', 'spread': '40.23', 'groupId': 'OG002'}]}]}, {'title': 'Insulin Glargine, 52 weeks (n=224, 227, 238)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Participants in this treatment arm were not exposed to Insulin Glargine.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Participants in this treatment arm were not exposed to Insulin Glargine.', 'groupId': 'OG001'}, {'value': '64.07', 'spread': '38.60', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 26 weeks and 52 weeks', 'description': 'Total daily insulin (TDI) dose was reported at baseline, 26 weeks, and 52 weeks. Daily Insulin Lispro and Insulin Glargine doses were reported at 26 and 52 weeks.', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 26 and 52 Weeks in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}, {'value': '294', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': '26 weeks', 'categories': [{'measurements': [{'value': '-0.87', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '2.33', 'spread': '0.27', 'groupId': 'OG002'}]}]}, {'title': '52 weeks', 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.86', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '2.89', 'spread': '0.33', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.20', 'ciLowerLimit': '-3.81', 'ciUpperLimit': '-2.59', 'pValueComment': 'Treatment comparison at 26 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.15', 'ciLowerLimit': '-2.76', 'ciUpperLimit': '-1.54', 'pValueComment': 'Treatment comparison at 26 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.23', 'ciLowerLimit': '-3.99', 'ciUpperLimit': '-2.48', 'pValueComment': 'Treatment comparison at 52 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.03', 'ciLowerLimit': '-2.78', 'ciUpperLimit': '-1.27', 'pValueComment': 'Treatment comparison at 52 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline body weight as a covariate.', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'Standard Error', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable body weight data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.'}, {'type': 'SECONDARY', 'title': 'Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '91.00', 'spread': '18.24', 'groupId': 'OG000'}, {'value': '91.69', 'spread': '18.03', 'groupId': 'OG001'}, {'value': '90.75', 'spread': '18.87', 'groupId': 'OG002'}]}]}, {'title': '52 weeks (n=290, 290, 295)', 'categories': [{'measurements': [{'value': '91.58', 'spread': '19.06', 'groupId': 'OG000'}, {'value': '93.21', 'spread': '19.23', 'groupId': 'OG001'}, {'value': '94.14', 'spread': '19.72', 'groupId': 'OG002'}]}]}, {'title': '4 weeks after last dose (n=259, 260, 253)', 'categories': [{'measurements': [{'value': '91.69', 'spread': '18.60', 'groupId': 'OG000'}, {'value': '93.14', 'spread': '19.20', 'groupId': 'OG001'}, {'value': '94.27', 'spread': '20.13', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 52 weeks and 4 weeks after last dose', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable body weight data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': '26 weeks (n=248, 251, 250)', 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '1.01', 'spread': '0.09', 'groupId': 'OG002'}]}]}, {'title': '52 weeks (n=225, 224, 232)', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '1.33', 'spread': '0.11', 'groupId': 'OG002'}]}]}, {'title': '4 weeks after last dose', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.20', 'ciLowerLimit': '-1.44', 'ciUpperLimit': '-0.96', 'pValueComment': 'Treatment comparison at 26 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.79', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '-0.55', 'pValueComment': 'Treatment comparison at 26 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.24', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '-0.94', 'pValueComment': 'Treatment comparison at 52 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.76', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '-0.46', 'pValueComment': 'Treatment comparison at 52 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline BMI as a covariate.', 'unitOfMeasure': 'kilograms per meter squared (kg/m^2)', 'dispersionType': 'Standard Error', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable BMI data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 26 and 52 Weeks in the EQ-5D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': 'EQ-5D UK, 26 weeks (n=272, 271, 274)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.01', 'groupId': 'OG002'}]}]}, {'title': 'EQ-5D UK, 52 weeks (n=274, 274, 281)', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.01', 'groupId': 'OG002'}]}]}, {'title': 'VAS, 26 weeks (n=278, 275, 275)', 'categories': [{'measurements': [{'value': '-1.69', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '-2.30', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '-0.60', 'spread': '1.00', 'groupId': 'OG002'}]}]}, {'title': 'VAS, 52 weeks (n=279, 278, 282)', 'categories': [{'measurements': [{'value': '-0.46', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '-2.54', 'spread': '1.02', 'groupId': 'OG001'}, {'value': '-0.18', 'spread': '1.01', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, metformin use, and baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable EQ-5D data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '294', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': '26 weeks (n=274, 270, 270)', 'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '-0.93', 'spread': '0.31', 'groupId': 'OG002'}]}]}, {'title': '52 weeks (n=277, 275, 279)', 'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-1.05', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '-1.28', 'spread': '0.33', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire \\[APPADL\\]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = "not at all difficult" and 1 = "unable to do". The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': '26 weeks (n=277, 274, 274)', 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': '52 weeks (n=278, 277, 281)', 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.16', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': "The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': '26 weeks (n=251, 256, 250)', 'categories': [{'measurements': [{'value': '3.75', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '2.91', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '2.83', 'spread': '1.30', 'groupId': 'OG002'}]}]}, {'title': '52 weeks (n=234, 238, 244)', 'categories': [{'measurements': [{'value': '2.51', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '2.38', 'spread': '1.23', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable LBSS data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': 'Amylase (total), 26 weeks (n=284, 282, 287)', 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '-2.00', 'upperLimit': '15.00'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '-1.00', 'upperLimit': '10.00'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '-4.00', 'upperLimit': '8.00'}]}]}, {'title': 'Amylase (total), 52 weeks (n=284, 283, 287)', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '-3.00', 'upperLimit': '12.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '-4.00', 'upperLimit': '9.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-7.00', 'upperLimit': '6.00'}]}]}, {'title': 'Amylase (PD), 26 weeks (n=284, 282, 287)', 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '10.00'}, {'value': '2.50', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '7.00'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '-2.00', 'upperLimit': '4.00'}]}]}, {'title': 'Amylase (PD), 52 weeks (n=284, 283, 287)', 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '-2.00', 'upperLimit': '9.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '-2.00', 'upperLimit': '5.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-3.00', 'upperLimit': '3.00'}]}]}, {'title': 'Lipase, 26 weeks (n=284, 282, 287)', 'categories': [{'measurements': [{'value': '7.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '17.00'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '-3.00', 'upperLimit': '12.00'}, {'value': '-2.00', 'groupId': 'OG002', 'lowerLimit': '-8.00', 'upperLimit': '3.00'}]}]}, {'title': 'Lipase, 52 weeks (n=284, 283, 287)', 'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000', 'lowerLimit': '-1.00', 'upperLimit': '16.50'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '-3.00', 'upperLimit': '11.00'}, {'value': '-2.00', 'groupId': 'OG002', 'lowerLimit': '-9.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'Amylase (total and pancreas-derived \\[PD\\]) and lipase concentrations were measured.', 'unitOfMeasure': 'units per liter (U/L)', 'dispersionType': 'Inter-Quartile Range', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.'}, {'type': 'SECONDARY', 'title': 'Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': 'Amylase (total), Baseline', 'categories': [{'measurements': [{'value': '61.21', 'spread': '27.89', 'groupId': 'OG000'}, {'value': '58.59', 'spread': '23.19', 'groupId': 'OG001'}, {'value': '61.18', 'spread': '26.69', 'groupId': 'OG002'}]}]}, {'title': 'Amylase (total), 52 weeks (n=284, 283, 287)', 'categories': [{'measurements': [{'value': '66.08', 'spread': '30.29', 'groupId': 'OG000'}, {'value': '60.97', 'spread': '25.78', 'groupId': 'OG001'}, {'value': '61.93', 'spread': '27.12', 'groupId': 'OG002'}]}]}, {'title': 'Amylase (total), 4 weeks ALD (n=251, 259, 251)', 'categories': [{'measurements': [{'value': '61.69', 'spread': '28.06', 'groupId': 'OG000'}, {'value': '59.21', 'spread': '30.32', 'groupId': 'OG001'}, {'value': '62.13', 'spread': '26.11', 'groupId': 'OG002'}]}]}, {'title': 'Amylase (PD), Baseline', 'categories': [{'measurements': [{'value': '26.56', 'spread': '14.51', 'groupId': 'OG000'}, {'value': '25.10', 'spread': '13.48', 'groupId': 'OG001'}, {'value': '26.43', 'spread': '15.94', 'groupId': 'OG002'}]}]}, {'title': 'Amylase (PD), 52 weeks (n=284, 283, 287)', 'categories': [{'measurements': [{'value': '31.38', 'spread': '18.15', 'groupId': 'OG000'}, {'value': '27.86', 'spread': '17.14', 'groupId': 'OG001'}, {'value': '26.91', 'spread': '17.64', 'groupId': 'OG002'}]}]}, {'title': 'Amylase (PD), 4 weeks ALD (n=251, 260, 251)', 'categories': [{'measurements': [{'value': '27.50', 'spread': '15.49', 'groupId': 'OG000'}, {'value': '25.77', 'spread': '13.78', 'groupId': 'OG001'}, {'value': '26.84', 'spread': '15.44', 'groupId': 'OG002'}]}]}, {'title': 'Lipase, Baseline', 'categories': [{'measurements': [{'value': '41.42', 'spread': '34.19', 'groupId': 'OG000'}, {'value': '41.08', 'spread': '32.80', 'groupId': 'OG001'}, {'value': '43.20', 'spread': '37.35', 'groupId': 'OG002'}]}]}, {'title': 'Lipase, 52 weeks (n=284, 283, 287)', 'categories': [{'measurements': [{'value': '50.57', 'spread': '35.65', 'groupId': 'OG000'}, {'value': '45.34', 'spread': '31.23', 'groupId': 'OG001'}, {'value': '39.39', 'spread': '27.51', 'groupId': 'OG002'}]}]}, {'title': 'Lipase, 4 weeks ALD (n=252, 260, 251)', 'categories': [{'measurements': [{'value': '44.19', 'spread': '36.92', 'groupId': 'OG000'}, {'value': '41.86', 'spread': '25.22', 'groupId': 'OG001'}, {'value': '43.02', 'spread': '35.75', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 52 weeks and 4 weeks after last dose', 'description': 'Amylase (total and pancreas-derived \\[PD\\]) and lipase concentrations were measured at baseline and at 4 weeks after last dose (ALD).', 'unitOfMeasure': 'units per liter (U/L)', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable pancreatic enzyme data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 26 and 52 Weeks in Serum Calcitonin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': '26 weeks (n=283, 282, 285)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': '52 weeks (n=283, 283, 285)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'unitOfMeasure': 'picogram per milliliter (pcg/mL)', 'dispersionType': 'Inter-Quartile Range', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing'}, {'type': 'SECONDARY', 'title': 'Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '0.78', 'spread': '0.88', 'groupId': 'OG002'}]}]}, {'title': '52 weeks (n=284, 283, 285)', 'categories': [{'measurements': [{'value': '0.79', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '0.80', 'spread': '0.89', 'groupId': 'OG002'}]}]}, {'title': '4 weeks after last dose (n=245, 254, 246)', 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '0.87', 'spread': '0.95', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 52 weeks and 4 weeks after last dose', 'unitOfMeasure': 'picomole per liter', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable serum calcitonin data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 26 and 52 Weeks in Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': 'SBP, 26 weeks (n=255, 261, 258)', 'categories': [{'measurements': [{'value': '-0.97', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '0.87', 'groupId': 'OG001'}, {'value': '2.23', 'spread': '0.88', 'groupId': 'OG002'}]}]}, {'title': 'SBP, 52 weeks (n=239, 240, 246)', 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '0.93', 'groupId': 'OG001'}, {'value': '1.98', 'spread': '0.92', 'groupId': 'OG002'}]}]}, {'title': 'DBP, 26 weeks (n=255, 261, 258)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '-0.23', 'spread': '0.56', 'groupId': 'OG002'}]}]}, {'title': 'DBP, 52 weeks (n=239, 240, 246)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '-0.34', 'spread': '0.56', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline blood pressure as a covariate.', 'unitOfMeasure': 'milliliters of mercury (mmHg)', 'dispersionType': 'Standard Error', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable blood pressure data.'}, {'type': 'SECONDARY', 'title': 'Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': 'SBP, Baseline', 'categories': [{'measurements': [{'value': '133.26', 'spread': '16.56', 'groupId': 'OG000'}, {'value': '134.03', 'spread': '15.87', 'groupId': 'OG001'}, {'value': '133.26', 'spread': '16.97', 'groupId': 'OG002'}]}]}, {'title': 'SBP, 52 weeks (n=290, 290, 295)', 'categories': [{'measurements': [{'value': '132.67', 'spread': '15.40', 'groupId': 'OG000'}, {'value': '134.31', 'spread': '16.41', 'groupId': 'OG001'}, {'value': '134.90', 'spread': '16.25', 'groupId': 'OG002'}]}]}, {'title': 'SBP, 4 weeks after last dose (n=260, 260, 255)', 'categories': [{'measurements': [{'value': '133.77', 'spread': '16.80', 'groupId': 'OG000'}, {'value': '134.72', 'spread': '16.50', 'groupId': 'OG001'}, {'value': '132.75', 'spread': '16.01', 'groupId': 'OG002'}]}]}, {'title': 'DBP, Baseline', 'categories': [{'measurements': [{'value': '77.33', 'spread': '9.73', 'groupId': 'OG000'}, {'value': '77.57', 'spread': '9.00', 'groupId': 'OG001'}, {'value': '77.18', 'spread': '10.41', 'groupId': 'OG002'}]}]}, {'title': 'DBP, 52 weeks (n=290, 290, 295)', 'categories': [{'measurements': [{'value': '77.33', 'spread': '9.63', 'groupId': 'OG000'}, {'value': '77.59', 'spread': '9.74', 'groupId': 'OG001'}, {'value': '77.07', 'spread': '9.92', 'groupId': 'OG002'}]}]}, {'title': 'DBP, 4 weeks after last dose (n=260, 260, 255)', 'categories': [{'measurements': [{'value': '76.58', 'spread': '10.06', 'groupId': 'OG000'}, {'value': '77.04', 'spread': '9.60', 'groupId': 'OG001'}, {'value': '76.94', 'spread': '9.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 52 weeks and 4 weeks after last dose', 'description': 'Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured.', 'unitOfMeasure': 'milliliters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable blood pressure data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 26 and 52 Weeks in Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': '26 weeks (n=255, 261, 258)', 'categories': [{'measurements': [{'value': '2.84', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '2.79', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '0.90', 'spread': '0.56', 'groupId': 'OG002'}]}]}, {'title': '52 weeks (n=239, 240, 246)', 'categories': [{'measurements': [{'value': '2.38', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '2.27', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '0.93', 'spread': '0.57', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline as a covariate', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Error', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable seated pulse rate data.'}, {'type': 'SECONDARY', 'title': 'Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '75.26', 'spread': '11.03', 'groupId': 'OG000'}, {'value': '75.08', 'spread': '11.10', 'groupId': 'OG001'}, {'value': '74.54', 'spread': '10.50', 'groupId': 'OG002'}]}]}, {'title': '52 weeks (n=290, 290, 295)', 'categories': [{'measurements': [{'value': '78.30', 'spread': '11.01', 'groupId': 'OG000'}, {'value': '77.83', 'spread': '10.90', 'groupId': 'OG001'}, {'value': '76.02', 'spread': '11.43', 'groupId': 'OG002'}]}]}, {'title': '4 weeks after last dose (n=260, 260, 255)', 'categories': [{'measurements': [{'value': '74.52', 'spread': '11.09', 'groupId': 'OG000'}, {'value': '74.99', 'spread': '11.98', 'groupId': 'OG001'}, {'value': '75.27', 'spread': '11.17', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 52 weeks and 4 weeks after last dose', 'description': 'Seated pulse rate was measured.', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable seated pulse rate data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': 'QTcF interval, 26 weeks (n=241, 242, 236)', 'categories': [{'measurements': [{'value': '0.29', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '1.12', 'groupId': 'OG001'}, {'value': '1.59', 'spread': '1.13', 'groupId': 'OG002'}]}]}, {'title': 'QTcF interval, 52 weeks (n= 222, 221, 221)', 'categories': [{'measurements': [{'value': '1.89', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '1.48', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '1.80', 'spread': '1.14', 'groupId': 'OG002'}]}]}, {'title': 'PR interval, 26 weeks (n=238, 243, 236)', 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '-1.75', 'spread': '0.94', 'groupId': 'OG001'}, {'value': '-1.13', 'spread': '0.95', 'groupId': 'OG002'}]}]}, {'title': 'PR interval, 52 weeks (n=220, 222, 221)', 'categories': [{'measurements': [{'value': '0.85', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '-0.43', 'spread': '1.00', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': "The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR\\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate.", 'unitOfMeasure': 'milliseconds (msec)', 'dispersionType': 'Standard Error', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG QTcF or PR Interval data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': '26 weeks (n=244, 246, 243)', 'categories': [{'measurements': [{'value': '3.95', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '4.18', 'spread': '0.65', 'groupId': 'OG001'}, {'value': '1.37', 'spread': '0.65', 'groupId': 'OG002'}]}]}, {'title': '52 weeks (n=230, 226, 230)', 'categories': [{'measurements': [{'value': '3.02', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '3.83', 'spread': '0.67', 'groupId': 'OG001'}, {'value': '1.03', 'spread': '0.67', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate.', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Error', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG heart rate data.'}, {'type': 'SECONDARY', 'title': 'Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': '26 weeks', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data from 26 weeks was not analyzed for this outcome.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data from 26 weeks was not analyzed for this outcome.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Data from 26 weeks was not analyzed for this outcome.', 'groupId': 'OG002'}]}]}, {'title': '52 weeks', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '4 weeks after last dose', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 52 weeks', 'description': 'The number of adjudicated (by an independent Clinical Endpoint Committee \\[CEC\\]) pancreatic events is summarized at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.', 'unitOfMeasure': 'events', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': 'Severe HE, 26 weeks', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Severe HE, 52 weeks', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Severe HE, 4 weeks after last dose', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG002'}]}]}, {'title': 'Documented Symptomatic HE, 26 weeks', 'categories': [{'measurements': [{'value': '228', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}, {'value': '243', 'groupId': 'OG002'}]}]}, {'title': 'Documented Symptomatic HE, 52 weeks', 'categories': [{'measurements': [{'value': '235', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}, {'value': '247', 'groupId': 'OG002'}]}]}, {'title': 'Documented Symptomatic HE, 4 weeks after last dose', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG002'}]}]}, {'title': 'Asymptomatic HE, 26 weeks', 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}]}, {'title': 'Asymptomatic HE, 52 weeks', 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '207', 'groupId': 'OG002'}]}]}, {'title': 'Asymptomatic HE, 4 weeks after last dose', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG002'}]}]}, {'title': 'Total HE, 26 weeks', 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}]}]}, {'title': 'Total HE, 52 weeks', 'categories': [{'measurements': [{'value': '252', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}]}, {'title': 'Total HE, 4 weeks after last dose', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Data from 4 weeks after last dose was not analyzed for this outcome.', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 26 weeks and 52 weeks', 'description': 'Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose \\[PG\\] of ≤ 70 milligrams per deciliter \\[mg/dL\\]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The number of participants with self-reported hypoglycemic events is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.', 'unitOfMeasure': 'participants', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used.'}, {'type': 'SECONDARY', 'title': 'Rate of Self-reported Hypoglycemic Events up to 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': 'Severe HE', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.43', 'groupId': 'OG002'}]}]}, {'title': 'Documented Symptomatic HE', 'categories': [{'measurements': [{'value': '30.98', 'spread': '39.64', 'groupId': 'OG000'}, {'value': '35.03', 'spread': '44.94', 'groupId': 'OG001'}, {'value': '39.90', 'spread': '50.92', 'groupId': 'OG002'}]}]}, {'title': 'Asymptomatic HE', 'categories': [{'measurements': [{'value': '9.55', 'spread': '19.52', 'groupId': 'OG000'}, {'value': '11.56', 'spread': '24.69', 'groupId': 'OG001'}, {'value': '14.20', 'spread': '23.19', 'groupId': 'OG002'}]}]}, {'title': 'Total HE', 'categories': [{'measurements': [{'value': '41.52', 'spread': '46.51', 'groupId': 'OG000'}, {'value': '47.42', 'spread': '54.39', 'groupId': 'OG001'}, {'value': '55.93', 'spread': '59.46', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 52 weeks', 'description': 'Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose \\[PG\\] of ≤ 70 milligrams per deciliter \\[mg/dL\\]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.', 'unitOfMeasure': 'events per participant per year', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': 'Any cardiovascular event', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Any fatal cardiovascular event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Any non-fatal cardiovascular event', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 52 weeks', 'description': 'Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.', 'unitOfMeasure': 'participants', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '562', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg or 0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg) or 0.75 mg , subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': '26 weeks', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data from 26 weeks was not analyzed for this outcome.', 'groupId': 'OG000'}]}]}, {'title': '52 weeks', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data from 52 weeks was not analyzed for this outcome.', 'groupId': 'OG000'}]}]}, {'title': '4 weeks after last dose', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 4 weeks after last dose', 'description': 'A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.', 'unitOfMeasure': 'participants', 'populationDescription': 'Participants who received at least one dose of LY2189265 with evaluable LY2189265 ADA data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'OG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'classes': [{'title': '26 weeks', 'categories': [{'measurements': [{'value': '203', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}]}, {'title': '52 weeks', 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}]}]}, {'title': '4 weeks after last dose', 'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 26 weeks, 52 weeks, and 4 weeks after last dose', 'description': 'A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks, 52 weeks, and 4 weeks after last dose. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.', 'unitOfMeasure': 'participants', 'populationDescription': 'Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'FG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'FG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '295'}, {'groupId': 'FG001', 'numSubjects': '293'}, {'groupId': 'FG002', 'numSubjects': '296'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '295'}, {'groupId': 'FG001', 'numSubjects': '293'}, {'groupId': 'FG002', 'numSubjects': '296'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '237'}, {'groupId': 'FG001', 'numSubjects': '238'}, {'groupId': 'FG002', 'numSubjects': '244'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '52'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'BG000'}, {'value': '293', 'groupId': 'BG001'}, {'value': '296', 'groupId': 'BG002'}, {'value': '884', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'BG001', 'title': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'BG002', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.88', 'spread': '9.55', 'groupId': 'BG000'}, {'value': '59.31', 'spread': '8.98', 'groupId': 'BG001'}, {'value': '59.90', 'spread': '9.08', 'groupId': 'BG002'}, {'value': '59.36', 'spread': '9.21', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '411', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '473', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '303', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}, {'value': '581', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '231', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}, {'value': '697', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '294', 'groupId': 'BG003'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '91.00', 'spread': '18.24', 'groupId': 'BG000'}, {'value': '91.69', 'spread': '18.03', 'groupId': 'BG001'}, {'value': '90.75', 'spread': '18.87', 'groupId': 'BG002'}, {'value': '91.14', 'spread': '18.37', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '31.99', 'spread': '5.11', 'groupId': 'BG000'}, {'value': '33.08', 'spread': '5.15', 'groupId': 'BG001'}, {'value': '32.41', 'spread': '5.33', 'groupId': 'BG002'}, {'value': '32.49', 'spread': '5.21', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared.', 'unitOfMeasure': 'kilograms per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycosylated Hemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.46', 'spread': '1.08', 'groupId': 'BG000'}, {'value': '8.40', 'spread': '1.03', 'groupId': 'BG001'}, {'value': '8.53', 'spread': '1.03', 'groupId': 'BG002'}, {'value': '8.46', 'spread': '1.05', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '12.80', 'spread': '7.19', 'groupId': 'BG000'}, {'value': '12.43', 'spread': '6.92', 'groupId': 'BG001'}, {'value': '12.96', 'spread': '6.80', 'groupId': 'BG002'}, {'value': '12.73', 'spread': '6.97', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Participants who were randomized and 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': 884}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'dispFirstSubmitDate': '2012-05-24', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-03', 'studyFirstSubmitDate': '2010-08-27', 'dispFirstSubmitQcDate': '2012-05-24', 'resultsFirstSubmitDate': '2014-10-03', 'studyFirstSubmitQcDate': '2010-08-27', 'dispFirstPostDateStruct': {'date': '2012-06-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-10-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-03', 'studyFirstPostDateStruct': {'date': '2010-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)', 'timeFrame': 'Baseline, 26 weeks', 'description': 'Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)', 'timeFrame': 'Baseline, 52 weeks', 'description': 'Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.'}, {'measure': 'Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52', 'timeFrame': '26 weeks and 52 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 repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model.'}, {'measure': 'Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'The percentage of participants achieving HbA1c less than 7.0% without nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking) or severe (episodes requiring the assistance of another person to actively administer resuscitative actions) hypoglycemia was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model.'}, {'measure': 'Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'The self-monitored plasma glucose (SMPG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. The mean of the 8 time points (Daily Mean) was also calculated. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.'}, {'measure': 'Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'Fasting serum glucose was measured by the central laboratory. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline fasting blood glucose as a covariate.'}, {'measure': 'Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine)', 'timeFrame': 'Baseline and 26 weeks and 52 weeks', 'description': 'Total daily insulin (TDI) dose was reported at baseline, 26 weeks, and 52 weeks. Daily Insulin Lispro and Insulin Glargine doses were reported at 26 and 52 weeks.'}, {'measure': 'Change From Baseline to 26 and 52 Weeks in Body Weight', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline body weight as a covariate.'}, {'measure': 'Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose', 'timeFrame': 'Baseline and 52 weeks and 4 weeks after last dose'}, {'measure': 'Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI)', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline BMI as a covariate.'}, {'measure': 'Change From Baseline to 26 and 52 Weeks in the EQ-5D', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, metformin use, and baseline.'}, {'measure': 'Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL)', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire \\[APPADL\\]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = "not at all difficult" and 1 = "unable to do". The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate.'}, {'measure': 'Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP)', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': "The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate."}, {'measure': 'Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS)', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate.'}, {'measure': 'Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'Amylase (total and pancreas-derived \\[PD\\]) and lipase concentrations were measured.'}, {'measure': 'Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose', 'timeFrame': 'Baseline and 52 weeks and 4 weeks after last dose', 'description': 'Amylase (total and pancreas-derived \\[PD\\]) and lipase concentrations were measured at baseline and at 4 weeks after last dose (ALD).'}, {'measure': 'Change From Baseline to 26 and 52 Weeks in Serum Calcitonin', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks'}, {'measure': 'Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose', 'timeFrame': 'Baseline and 52 weeks and 4 weeks after last dose'}, {'measure': 'Change From Baseline to 26 and 52 Weeks in Blood Pressure', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline blood pressure as a covariate.'}, {'measure': 'Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose', 'timeFrame': 'Baseline and 52 weeks and 4 weeks after last dose', 'description': 'Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured.'}, {'measure': 'Change From Baseline to 26 and 52 Weeks in Pulse Rate', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline as a covariate'}, {'measure': 'Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose', 'timeFrame': 'Baseline and 52 weeks and 4 weeks after last dose', 'description': 'Seated pulse rate was measured.'}, {'measure': 'Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': "The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR\\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate."}, {'measure': 'Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate', 'timeFrame': 'Baseline, 26 weeks, and 52 weeks', 'description': 'Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate.'}, {'measure': 'Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose', 'timeFrame': 'Baseline through 52 weeks', 'description': 'The number of adjudicated (by an independent Clinical Endpoint Committee \\[CEC\\]) pancreatic events is summarized at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.'}, {'measure': 'Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose', 'timeFrame': 'Baseline through 26 weeks and 52 weeks', 'description': 'Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose \\[PG\\] of ≤ 70 milligrams per deciliter \\[mg/dL\\]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The number of participants with self-reported hypoglycemic events is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.'}, {'measure': 'Rate of Self-reported Hypoglycemic Events up to 52 Weeks', 'timeFrame': 'Baseline through 52 weeks', 'description': 'Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose \\[PG\\] of ≤ 70 milligrams per deciliter \\[mg/dL\\]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.'}, {'measure': 'Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks', 'timeFrame': 'Baseline through 52 weeks', 'description': 'Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.'}, {'measure': 'Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose', 'timeFrame': 'Baseline through 4 weeks after last dose', 'description': 'A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose', 'timeFrame': 'Baseline through 26 weeks, 52 weeks, and 4 weeks after last dose', 'description': 'A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks, 52 weeks, and 4 weeks after last dose. 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': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '29430801', 'type': 'DERIVED', 'citation': 'Pantalone KM, Patel H, Yu M, Fernandez Lando L. Dulaglutide 1.5 mg as an add-on option for patients uncontrolled on insulin: Subgroup analysis by age, duration of diabetes and baseline glycated haemoglobin concentration. Diabetes Obes Metab. 2018 Jun;20(6):1461-1469. doi: 10.1111/dom.13252. Epub 2018 Mar 23.'}, {'pmid': '27161178', 'type': 'DERIVED', 'citation': 'Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.'}, {'pmid': '26691396', 'type': 'DERIVED', 'citation': 'Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.'}, {'pmid': '26009229', 'type': 'DERIVED', 'citation': 'Blonde L, Jendle J, Gross J, Woo V, Jiang H, Fahrbach JL, Milicevic Z. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015 May 23;385(9982):2057-66. doi: 10.1016/S0140-6736(15)60936-9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.', 'detailedDescription': 'The term rescue therapy in this trial was defined as therapy for participants who met criteria for persistent severe hyperglycemia and therapy for participants who required new intervention for any other reason. The latter included participants who discontinued study drug due to adverse events, participant decision, or any other reason. For efficacy analyses, participants who received rescue medication were included in the analysis population, but only measurements obtained prior to taking rescue therapy were included in the efficacy analysis. For safety analyses, with the exception of hypoglycemia, all measurements including those obtained after taking rescue therapy were included in the analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Currently using insulin for at least 3 months with a conventional insulin regimen with or without oral medications\n* Glycosylated hemoglobin (HbA1c) greater than or equal to 7% and less than or equal to 11%\n* Willing to inject subcutaneous medication\n* Willing to monitor blood glucose levels and adjust insulin dose\n* Willing to maintain a study diary\n* Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m\\^2)\n* Stable weight for 3 months prior to screening\n* Females of child bearing potential must test negative for pregnancy at screening and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug\n\nExclusion Criteria:\n\n* Type 1 Diabetes\n* Previous therapy with glucagon-like peptide 1 (GLP-1) agonists within 3 months prior to screening\n* 1 or more episodes of ketoacidosis within 6 months prior to screening\n* Have been treated with prescription or over the counter medication to promote weight loss within 3 months prior to screening\n* Estimated glomerular filtration rate (eGFR) less than or equal to 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\\^2) at screening\n* Taking steroids for greater than 14 days except for topical, eye, nasal, or inhaled\n* History of heart failure, New York Heart Classification III or IV within 2 months prior to screening\n* Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking medications that directly affect GI motility\n* Acute or chronic hepatitis or pancreatitis\n* Self or family history of 2A or type 2B multiple endocrine neoplasia or medullary C-Cell hyperplasia\n* Serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/mL) at screening\n* Organ transplant except cornea\n* Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis\n* History of or active malignancy except skin or in situ cervical or prostate cancer within the last 5 years\n* Known drug or alcohol abuse\n* Have enrolled in another clinical trial within the last 30 days\n* Have previously signed an informed consent or participated in a LY2189265 study'}, 'identificationModule': {'nctId': 'NCT01191268', 'briefTitle': 'A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'The Impact of LY2189265 Versus Insulin Glargine in Combination With Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus (AWARD-4: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 4)', 'orgStudyIdInfo': {'id': '11376'}, 'secondaryIdInfos': [{'id': 'H9X-MC-GBDD', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1.5 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks', 'interventionNames': ['Drug: LY2189265', 'Drug: Insulin Lispro']}, {'type': 'EXPERIMENTAL', 'label': '0.75 mg LY2189265', 'description': 'LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks', 'interventionNames': ['Drug: LY2189265', 'Drug: Insulin Lispro']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Glargine', 'description': 'Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks\n\nInsulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks', 'interventionNames': ['Drug: Insulin Glargine', 'Drug: Insulin Lispro']}], 'interventions': [{'name': 'Insulin Glargine', 'type': 'DRUG', 'armGroupLabels': ['Insulin Glargine']}, {'name': 'LY2189265', 'type': 'DRUG', 'otherNames': ['Dulaglutide'], 'armGroupLabels': ['0.75 mg LY2189265', '1.5 mg LY2189265']}, {'name': 'Insulin Lispro', 'type': 'DRUG', 'armGroupLabels': ['0.75 mg LY2189265', '1.5 mg LY2189265', 'Insulin Glargine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', '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': 37.97798, 'lon': -122.03107}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', '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': 32.76783, 'lon': -117.02308}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', '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': 34.69804, 'lon': -118.13674}}, {'zip': '06050', 'city': 'New Britain', 'state': 'Connecticut', 'country': 'United States', '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': 41.66121, 'lon': -72.77954}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', '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': 26.0112, 'lon': -80.14949}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', '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': 30.33218, 'lon': -81.65565}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', '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': 26.71534, 'lon': -80.05337}}, {'zip': '33880', 'city': 'Winter Haven', 'state': 'Florida', 'country': 'United States', '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': 28.02224, 'lon': -81.73286}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', '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': 21.30694, 'lon': -157.85833}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', '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': 39.76838, 'lon': -86.15804}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', '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': 39.04833, 'lon': -95.67804}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', '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': 37.98869, 'lon': -84.47772}}, {'zip': '42003', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', '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': 37.08339, 'lon': -88.60005}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', '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': 29.98409, 'lon': -90.15285}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', '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': 29.95465, 'lon': -90.07507}}, {'zip': '01830', 'city': 'Haverhill', 'state': 'Massachusetts', 'country': 'United States', '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': 42.7762, 'lon': -71.07728}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', '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': 42.10148, 'lon': -72.58981}}, {'zip': '02453', 'city': 'Waltham', 'state': 'Massachusetts', 'country': 'United States', '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': 42.37649, 'lon': -71.23561}}, {'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', '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': 42.26259, 'lon': -71.80229}}, {'zip': '55416', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', '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': 44.97997, 'lon': -93.26384}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', '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': 38.66311, 'lon': -90.57707}}, {'zip': '03063', 'city': 'Nashua', 'state': 'New Hampshire', 'country': 'United States', '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': 42.76537, 'lon': -71.46757}}, {'zip': '08753', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', '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': 39.95373, 'lon': -74.19792}}, {'zip': '12206', 'city': 'Albany', 'state': 'New York', 'country': 'United States', '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': 42.65258, 'lon': -73.75623}}, {'zip': '28803', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', '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': 35.60095, 'lon': -82.55402}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', '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': 34.72294, 'lon': -76.72604}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', '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': 46.87719, 'lon': -96.7898}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', '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': 44.05207, 'lon': -123.08675}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', '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': 33.68906, 'lon': -78.88669}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', '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': 35.14953, 'lon': -90.04898}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', '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': 30.26715, 'lon': -97.74306}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', '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': 32.78306, 'lon': -96.80667}}, {'zip': '98003', 'city': 'Federal Way', 'state': 'Washington', 'country': 'United States', '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': 47.32232, 'lon': -122.31262}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', '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': 47.48288, 'lon': -122.21707}}, {'zip': '98664', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', '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': 45.63873, 'lon': -122.66149}}, {'zip': '98801', 'city': 'Wenatchee', 'state': 'Washington', 'country': 'United States', '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': 47.42346, 'lon': -120.31035}}, {'zip': 'C1034ACO', 'city': 'Buenos Aires', 'country': 'Argentina', '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': -34.61315, 'lon': -58.37723}}, {'zip': '8324', 'city': 'Cipolletti', 'country': 'Argentina', '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': -38.93392, 'lon': -67.99032}}, {'zip': 'M5500CCE', 'city': 'Mendoza', 'country': 'Argentina', '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': -32.88946, 'lon': -68.84582}}, {'zip': '4406', 'city': 'Salta', 'country': 'Argentina', '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': -24.80645, 'lon': -65.41999}}, {'zip': '5035', 'city': 'Keswick', 'state': 'South Australia', 'country': 'Australia', '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': -34.94178, 'lon': 138.57459}}, {'zip': '3128', 'city': 'Box Hill', 'state': 'Victoria', 'country': 'Australia', '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': -37.81887, 'lon': 145.12545}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', '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': -37.814, 'lon': 144.96332}}, {'zip': '2820', 'city': 'Bonheiden', 'country': 'Belgium', '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': 51.02261, 'lon': 4.54714}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', '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': 50.85045, 'lon': 4.34878}}, {'zip': '3600', 'city': 'Genk', 'country': 'Belgium', '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': 50.965, 'lon': 5.50082}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', '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': 50.63373, 'lon': 5.56749}}, {'zip': '66073-000', 'city': 'Belém', 'country': 'Brazil', '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': -1.45583, 'lon': -48.50444}}, {'zip': '60430-350', 'city': 'Fortaleza', 'country': 'Brazil', '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': -3.71722, 'lon': -38.54306}}, {'zip': '90035-170', 'city': 'Porto Alegre', 'country': 'Brazil', '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': -30.03283, 'lon': -51.23019}}, {'zip': '04266-010', 'city': 'São Paulo', 'country': 'Brazil', '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': -23.5475, 'lon': -46.63611}}, {'zip': 'V3L 3W5', 'city': 'New Westminster', 'state': 'British Columbia', 'country': 'Canada', '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': 49.20678, 'lon': -122.91092}}, {'zip': 'R3E 3P4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', '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': 49.8844, 'lon': -97.14704}}, {'zip': 'N6G 4X8', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', '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': 42.98339, 'lon': -81.23304}}, {'zip': 'J8V 2P5', 'city': 'Gatineau', 'state': 'Quebec', 'country': 'Canada', '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': 45.47723, 'lon': -75.70164}}, {'zip': 'J1G 5K2', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', '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': 45.40008, 'lon': -71.89908}}, {'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', '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': 56.15674, 'lon': 10.21076}}, {'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', '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': 55.67594, 'lon': 12.56553}}, {'zip': 'Dk-3400', 'city': 'Hillerød', 'country': 'Denmark', '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': 55.92791, 'lon': 12.30081}}, {'zip': '4600', 'city': 'Koege', 'country': 'Denmark', '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': '6000', 'city': 'Kolding', 'country': 'Denmark', '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': 55.4904, 'lon': 9.47216}}, {'zip': '11527', 'city': 'Ampelokipoi', 'country': 'Greece', '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': 37.75809, 'lon': 20.87248}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', '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': 37.98376, 'lon': 23.72784}}, {'zip': '18454', 'city': 'Nikaias - Piraeus', 'country': 'Greece', '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': '54639', 'city': 'Thessaloniki', 'country': 'Greece', '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': 40.64072, 'lon': 22.93493}}, {'zip': '5600', 'city': 'Békéscsaba', 'country': 'Hungary', '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': 46.68333, 'lon': 21.1}}, {'zip': '1115', 'city': 'Budapest', 'country': 'Hungary', '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': 47.49835, 'lon': 19.04045}}, {'zip': '3200', 'city': 'Gyöngyös', 'country': 'Hungary', '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': 47.78257, 'lon': 19.928}}, {'zip': '3529', 'city': 'Miskolc', 'country': 'Hungary', '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': 48.10327, 'lon': 20.77806}}, {'zip': '8800', 'city': 'Nagykanizsa', 'country': 'Hungary', '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': 46.45347, 'lon': 16.99104}}, {'zip': '4400', 'city': 'Nyíregyháza', 'country': 'Hungary', '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': 47.95539, 'lon': 21.71671}}, {'zip': '8500', 'city': 'Pápa', 'country': 'Hungary', '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': 47.33004, 'lon': 17.4674}}, {'zip': '80020', 'city': 'Culiacán', 'country': 'Mexico', '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': 24.80209, 'lon': -107.39421}}, {'zip': '44650', 'city': 'Guadalajara', 'country': 'Mexico', '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': 20.67738, 'lon': -103.34749}}, {'zip': '97070', 'city': 'Mérida', 'country': 'Mexico', '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': 20.967, 'lon': -89.62318}}, {'zip': '64461', 'city': 'Monterrey', 'country': 'Mexico', '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': 25.68435, 'lon': -100.31721}}, {'zip': '81-557', 'city': 'Gdynia', 'country': 'Poland', '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': 54.51889, 'lon': 18.53188}}, {'zip': '90-242', 'city': 'Lodz', 'country': 'Poland', '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': 51.77058, 'lon': 19.47395}}, {'zip': '05-250', 'city': 'Radzymin', 'country': 'Poland', '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': 52.41592, 'lon': 21.18415}}, {'zip': '50-349', 'city': 'Wroclaw', 'country': 'Poland', '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': 51.10286, 'lon': 17.03006}}, {'zip': '00674', 'city': 'Manatí', 'country': 'Puerto Rico', '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': 18.42745, 'lon': -66.49212}}, {'zip': '00728', 'city': 'Ponce', 'country': 'Puerto Rico', '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': 18.01031, 'lon': -66.62398}}, {'zip': '00917-3104', 'city': 'San Juan', 'country': 'Puerto Rico', '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': 18.46633, 'lon': -66.10572}}, {'zip': '00767', 'city': 'Yabucoa', 'country': 'Puerto Rico', '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': 18.05052, 'lon': -65.87933}}, {'zip': '127486', 'city': 'Moscow', 'country': 'Russia', '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': 55.75204, 'lon': 37.61781}}, {'zip': '191126', 'city': 'Saint Petersburg', 'country': 'Russia', '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': 59.93863, 'lon': 30.31413}}, {'zip': '443095', 'city': 'Samara', 'country': 'Russia', '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': 53.20767, 'lon': 50.13553}}, {'zip': '08022', 'city': 'Barcelona', 'country': 'Spain', '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': 41.38879, 'lon': 2.15899}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', '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': 40.4165, 'lon': -3.70256}}, {'zip': '07010', 'city': 'Palma de Mallorca', 'country': 'Spain', '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': 39.56939, 'lon': 2.65024}}, {'zip': '28223', 'city': 'Pozuelo de Alarcón', 'country': 'Spain', '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': 40.43293, 'lon': -3.81338}}, {'zip': '44002', 'city': 'Teruel', 'country': 'Spain', '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': 40.3456, 'lon': -1.10646}}, {'zip': '46014', 'city': 'Valencia', 'country': 'Spain', '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': 39.47391, 'lon': -0.37966}}, {'zip': '65185', 'city': 'Karlstad', 'country': 'Sweden', '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': 59.3793, 'lon': 13.50357}}, {'zip': '22185', 'city': 'Lund', 'country': 'Sweden', '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': 55.70584, 'lon': 13.19321}}, {'zip': '113 61', 'city': 'Stockholm', 'country': 'Sweden', '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': 59.32938, 'lon': 18.06871}}, {'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', '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': 22.61626, 'lon': 120.31333}}, {'zip': '23148', 'city': 'Sindian City', 'country': 'Taiwan', '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': 24.94062, 'lon': 121.53111}}, {'zip': '404', 'city': 'Taichung', 'country': 'Taiwan', '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': 24.1469, 'lon': 120.6839}}, {'zip': '11031', 'city': 'Taipei', 'country': 'Taiwan', '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': 25.05306, 'lon': 121.52639}}, {'zip': '710', 'city': 'Yongkang District', 'country': 'Taiwan', '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': 23.02444, 'lon': 120.25556}}], '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'}}}}