Viewing Study NCT03495102

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 3:53 AM
Ignite Modification Date: 2025-12-26 @ 2:42 AM
Study NCT ID: NCT03495102
Status: COMPLETED
Last Update Posted: 2020-06-12
First Post: 2018-04-02
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555680', 'term': 'dulaglutide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 56', 'description': 'All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Dulaglutide 1.5 mg', 'description': 'Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.', 'otherNumAtRisk': 612, 'deathsNumAtRisk': 612, 'otherNumAffected': 156, 'seriousNumAtRisk': 612, 'deathsNumAffected': 3, 'seriousNumAffected': 53}, {'id': 'EG001', 'title': 'Dulaglutide 3 mg', 'description': 'Dulaglutide 3 mg administered SC once a week.', 'otherNumAtRisk': 616, 'deathsNumAtRisk': 616, 'otherNumAffected': 190, 'seriousNumAtRisk': 616, 'deathsNumAffected': 4, 'seriousNumAffected': 45}, {'id': 'EG002', 'title': 'Dulaglutide 4.5 mg', 'description': 'Dulaglutide 4.5 mg administered SC once a week.', 'otherNumAtRisk': 614, 'deathsNumAtRisk': 614, 'otherNumAffected': 195, 'seriousNumAtRisk': 614, 'deathsNumAffected': 4, 'seriousNumAffected': 38}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 83, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 118, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 176, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 26, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 56, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 35, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 121, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 180, 'numAffected': 99}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 192, 'numAffected': 106}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 63, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 89, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 108, 'numAffected': 64}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 38, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 41, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 48, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Blood loss anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Acute vestibular syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Mesenteric vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Medical device site joint inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Jaundice cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Abscess neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Campylobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Infective exacerbation of chronic obstructive airways disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Perinephric abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Periorbital cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pyoderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Renal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'West nile viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Comminuted fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Exposure to toxic agent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Limb traumatic amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Ecg signs of myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Electrocardiogram t wave inversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Osteoarthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Plica syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Adenocarcinoma pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Bladder cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Clear cell renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Metastases to abdominal cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Metastatic uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, '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 22.1'}, {'term': 'Neuroendocrine tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Phaeochromocytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, '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 22.1'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cerebral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Diabetic mononeuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': "Wernicke's encephalopathy", 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cervical polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Oedema genital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypersensitivity pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 614, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Hemoglobin A1c (HbA1c) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '523', 'groupId': 'OG000'}, {'value': '521', 'groupId': 'OG001'}, {'value': '526', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dulaglutide 1.5 mg', 'description': 'Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.'}, {'id': 'OG001', 'title': 'Dulaglutide 3 mg', 'description': 'Dulaglutide 3 mg administered SC once a week.'}, {'id': 'OG002', 'title': 'Dulaglutide 4.5 mg', 'description': 'Dulaglutide 4.5 mg administered SC once a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.53', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-1.71', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '-1.87', 'spread': '0.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '-0.06', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '-0.22', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables:Baseline + Pooled Country + Treatment + Time + Treatment\\*Time (Type III sum of squares).', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline HbA1c value, excluding data post treatment discontinuation and/or initiation of new antihyperglycemic medications.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '522', 'groupId': 'OG000'}, {'value': '520', 'groupId': 'OG001'}, {'value': '526', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dulaglutide 1.5 mg', 'description': 'Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.'}, {'id': 'OG001', 'title': 'Dulaglutide 3 mg', 'description': 'Dulaglutide 3 mg administered SC once a week.'}, {'id': 'OG002', 'title': 'Dulaglutide 4.5 mg', 'description': 'Dulaglutide 4.5 mg administered SC once a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '-4.7', 'spread': '0.19', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '-1.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment\\*Time (Type III sum of squares).', 'unitOfMeasure': 'Kilograms (Kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline body weight value, excluding data post treatment discontinuation and/or initiation of new antihyperglycemic medications.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving HbA1c Target <7.0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '523', 'groupId': 'OG000'}, {'value': '521', 'groupId': 'OG001'}, {'value': '526', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dulaglutide 1.5 mg', 'description': 'Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.'}, {'id': 'OG001', 'title': 'Dulaglutide 3 mg', 'description': 'Dulaglutide 3 mg administered SC once a week.'}, {'id': 'OG002', 'title': 'Dulaglutide 4.5 mg', 'description': 'Dulaglutide 4.5 mg administered SC once a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.98', 'groupId': 'OG000'}, {'value': '64.68', 'groupId': 'OG001'}, {'value': '71.48', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '1.12', 'ciUpperLimit': '1.98', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.23', 'ciLowerLimit': '1.65', 'ciUpperLimit': '3.01', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': 'Percentage of participants achieving HbA1c target \\<7.0%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline HbA1c value, excluding data post treatment discontinuation and/or initiation of new antihyperglycemic medications.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Serum Glucose (FSG) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}, {'value': '514', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dulaglutide 1.5 mg', 'description': 'Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.'}, {'id': 'OG001', 'title': 'Dulaglutide 3 mg', 'description': 'Dulaglutide 3 mg administered SC once a week.'}, {'id': 'OG002', 'title': 'Dulaglutide 4.5 mg', 'description': 'Dulaglutide 4.5 mg administered SC once a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '-44.2', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '-47.9', 'spread': '1.50', 'groupId': 'OG001'}, {'value': '-52.3', 'spread': '1.50', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.084', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.7', 'ciLowerLimit': '-7.8', 'ciUpperLimit': '0.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.1', 'ciLowerLimit': '-12.3', 'ciUpperLimit': '-3.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment\\*Time (Type III sum of squares).', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline FSG value, excluding data post treatment discontinuation and/or initiation of new antihyperglycemic medications.'}, {'type': 'SECONDARY', 'title': 'Rate of Documented Symptomatic Hypoglycemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '616', 'groupId': 'OG001'}, {'value': '614', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dulaglutide 1.5 mg', 'description': 'Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.'}, {'id': 'OG001', 'title': 'Dulaglutide 3 mg', 'description': 'Dulaglutide 3 mg administered SC once a week.'}, {'id': 'OG002', 'title': 'Dulaglutide 4.5 mg', 'description': 'Dulaglutide 4.5 mg administered SC once a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.01', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 36', 'description': 'Hypoglycemia was defined as blood glucose \\< 54 mg/dL, excluding post-rescue records. Estimate is based on Group Mean from negative binomial model. The negative binomial model for post-baseline comparisons between treatments and control group: Number of episodes = Pooled Country + HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.', 'unitOfMeasure': 'Episodes/participant/365.25 days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '616', 'groupId': 'OG001'}, {'value': '614', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dulaglutide 1.5 mg', 'description': 'Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.'}, {'id': 'OG001', 'title': 'Dulaglutide 3 mg', 'description': 'Dulaglutide 3 mg administered SC once a week.'}, {'id': 'OG002', 'title': 'Dulaglutide 4.5 mg', 'description': 'Dulaglutide 4.5 mg administered SC once a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.6', 'groupId': 'OG000', 'lowerLimit': '77.7', 'upperLimit': '81.7'}, {'value': '159', 'groupId': 'OG001', 'lowerLimit': '155', 'upperLimit': '163'}, {'value': '238', 'groupId': 'OG002', 'lowerLimit': '232', 'upperLimit': '243'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4, Week 12, Week 36, Week 52', 'description': 'Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss).', 'unitOfMeasure': 'nanogram/milliliter (ng/mL)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '616', 'groupId': 'OG001'}, {'value': '614', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dulaglutide 1.5 mg', 'description': 'Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.'}, {'id': 'OG001', 'title': 'Dulaglutide 3 mg', 'description': 'Dulaglutide 3 mg administered SC once a week.'}, {'id': 'OG002', 'title': 'Dulaglutide 4.5 mg', 'description': 'Dulaglutide 4.5 mg administered SC once a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '11200', 'groupId': 'OG000', 'lowerLimit': '10900', 'upperLimit': '11500'}, {'value': '22300', 'groupId': 'OG001', 'lowerLimit': '21800', 'upperLimit': '22900'}, {'value': '33400', 'groupId': 'OG002', 'lowerLimit': '32700', 'upperLimit': '34200'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4, Week 12, Week 36, Week 52', 'description': 'Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State.', 'unitOfMeasure': 'nanogram*hour/milliliter (ng*h/mL)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dulaglutide 1.5 mg', 'description': 'Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.'}, {'id': 'FG001', 'title': 'Dulaglutide 3 mg', 'description': 'Dulaglutide 3 mg administered SC once a week.'}, {'id': 'FG002', 'title': 'Dulaglutide 4.5 mg', 'description': 'Dulaglutide 4.5 mg administered SC once a week.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '612'}, {'groupId': 'FG001', 'numSubjects': '616'}, {'groupId': 'FG002', 'numSubjects': '614'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '612'}, {'groupId': 'FG001', 'numSubjects': '616'}, {'groupId': 'FG002', 'numSubjects': '614'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '556'}, {'groupId': 'FG001', 'numSubjects': '549'}, {'groupId': 'FG002', 'numSubjects': '560'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '67'}, {'groupId': 'FG002', 'numSubjects': '54'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Site Closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant Duplicated at Another Site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Primary Care Physician Recommendation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Relocated to Another Country', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant was in Rehabilitation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'BG000'}, {'value': '616', 'groupId': 'BG001'}, {'value': '614', 'groupId': 'BG002'}, {'value': '1842', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Dulaglutide 1.5 mg', 'description': 'Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.'}, {'id': 'BG001', 'title': 'Dulaglutide 3 mg', 'description': 'Dulaglutide 3 mg administered SC once a week.'}, {'id': 'BG002', 'title': 'Dulaglutide 4.5 mg', 'description': 'Dulaglutide 4.5 mg administered SC once a week.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '56.9', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '56.6', 'spread': '10.2', 'groupId': 'BG002'}, {'value': '57.1', 'spread': '10.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '314', 'groupId': 'BG000'}, {'value': '288', 'groupId': 'BG001'}, {'value': '296', 'groupId': 'BG002'}, {'value': '898', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '298', 'groupId': 'BG000'}, {'value': '328', 'groupId': 'BG001'}, {'value': '318', 'groupId': 'BG002'}, {'value': '944', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}, {'value': '641', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '369', 'groupId': 'BG000'}, {'value': '363', 'groupId': 'BG001'}, {'value': '371', 'groupId': 'BG002'}, {'value': '1103', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '529', 'groupId': 'BG000'}, {'value': '521', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}, {'value': '1580', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '42', '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', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '290', 'groupId': 'BG003'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '233', 'groupId': 'BG003'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}, {'value': '508', 'groupId': 'BG003'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Hemoglobin A1C (HbA1c) at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '8.64', 'spread': '0.94', 'groupId': 'BG000'}, {'value': '8.63', 'spread': '1.00', 'groupId': 'BG001'}, {'value': '8.64', 'spread': '0.91', 'groupId': 'BG002'}, {'value': '8.64', 'spread': '0.95', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All participants who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-05', 'size': 800584, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-17T16:08', 'hasProtocol': True}, {'date': '2019-06-06', 'size': 635510, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-17T16:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1842}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12-15', 'completionDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2018-04-02', 'resultsFirstSubmitDate': '2020-05-28', 'studyFirstSubmitQcDate': '2018-04-10', 'lastUpdatePostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-28', 'studyFirstPostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hemoglobin A1c (HbA1c) From Baseline', 'timeFrame': 'Baseline, Week 36', 'description': 'HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables:Baseline + Pooled Country + Treatment + Time + Treatment\\*Time (Type III sum of squares).'}], 'secondaryOutcomes': [{'measure': 'Change in Body Weight From Baseline', 'timeFrame': 'Baseline, Week 36', 'description': 'Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment\\*Time (Type III sum of squares).'}, {'measure': 'Percentage of Participants Achieving HbA1c Target <7.0%', 'timeFrame': 'Week 36', 'description': 'Percentage of participants achieving HbA1c target \\<7.0%.'}, {'measure': 'Change in Fasting Serum Glucose (FSG) From Baseline', 'timeFrame': 'Baseline, Week 36', 'description': 'Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment\\*Time (Type III sum of squares).'}, {'measure': 'Rate of Documented Symptomatic Hypoglycemic Episodes', 'timeFrame': 'Week 36', 'description': 'Hypoglycemia was defined as blood glucose \\< 54 mg/dL, excluding post-rescue records. Estimate is based on Group Mean from negative binomial model. The negative binomial model for post-baseline comparisons between treatments and control group: Number of episodes = Pooled Country + HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.'}, {'measure': 'Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)', 'timeFrame': 'Week 4, Week 12, Week 36, Week 52', 'description': 'Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss).'}, {'measure': 'Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State', 'timeFrame': 'Week 4, Week 12, Week 36, Week 52', 'description': 'Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '36894938', 'type': 'DERIVED', 'citation': 'Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.'}, {'pmid': '35546790', 'type': 'DERIVED', 'citation': 'Cox DA, Wang H, Nicolay C, Bethel MA. Effect of expanded dulaglutide weekly doses (3.0 mg and 4.5 mg) on cardiovascular disease risk factors in participants with type 2 diabetes at increased cardiovascular disease risk: a post hoc analysis of the AWARD-11 study. Diabetes Obes Metab. 2022 Sep;24(9):1770-1778. doi: 10.1111/dom.14762. Epub 2022 May 29.'}, {'pmid': '33397768', 'type': 'DERIVED', 'citation': 'Frias JP, Bonora E, Nevarez Ruiz L, Li YG, Yu Z, Milicevic Z, Malik R, Bethel MA, Cox DA. Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11). Diabetes Care. 2021 Mar;44(3):765-773. doi: 10.2337/dc20-1473. Epub 2021 Jan 4.'}], 'seeAlsoLinks': [{'url': 'https://www.lillytrialguide.com/en-US/studies/adult-type-2-diabetes/GBGL#?postal=', 'label': 'A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes (AWARD-11)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of investigational doses of once weekly dulaglutide when added to metformin in participants with type 2 diabetes with inadequate blood sugar control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have type 2 diabetes mellitus (T2DM) for at least 6 months\n* Have been treated with stable metformin dose for at least 3 months\n* Have HbA1c ≥7.5% and ≤11.0% at study entry\n* Have body mass index (BMI) ≥25 kilograms per meter squared (kg/m\\^2)\n\nExclusion Criteria:\n\n* Have type 1 diabetes mellitus\n* Have used any glucagon-like peptide-1 receptor agonist (GLP-1 RA) or insulin, not including prior short term insulin use (≤14 days)\n* Have been taking any other medicine for diabetes (other than metformin) during the last 3 months\n* Have used in the last 3 months (or plan to use) prescription weight loss medications\n* Have disorders associated with slowed emptying of the stomach contents, or have had any stomach surgeries for the purpose of weight loss\n* Current participation in or intent to begin during the study an organized diet and/or exercise weight reduction program (other than the lifestyle and dietary measures for diabetes)\n* Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level \\>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial\n* Had chronic or acute pancreatitis any time prior to study entry\n* Have had a heart attack or stroke in the past 2 months, or have heart failure that significantly limits their physical activity\n* Estimated glomerular filtration rate (eGFR) \\<30 milliliters/minute/1.73m\\^2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead-in\n* Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2\n* Have proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator'}, 'identificationModule': {'nctId': 'NCT03495102', 'acronym': 'AWARD-11', 'briefTitle': 'A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Investigational Dulaglutide Doses When Added to Metformin in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '16877'}, 'secondaryIdInfos': [{'id': 'H9X-MC-GBGL', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2017-003490-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dulaglutide 1.5 mg', 'description': 'Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.', 'interventionNames': ['Drug: Dulaglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Dulaglutide 3 mg', 'description': 'Dulaglutide 3 mg administered SC once a week.', 'interventionNames': ['Drug: Dulaglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Dulaglutide 4.5 mg', 'description': 'Dulaglutide 4.5 mg administered SC once a week.', 'interventionNames': ['Drug: Dulaglutide']}], 'interventions': [{'name': 'Dulaglutide', 'type': 'DRUG', 'otherNames': ['LY2189265'], 'description': 'Administered SC', 'armGroupLabels': ['Dulaglutide 1.5 mg', 'Dulaglutide 3 mg', 'Dulaglutide 4.5 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Synexus- Chandler', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Synexus/Central Arizona Medical Associates, PC', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Central Phoenix Med Clinic LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Clinical Research', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials, LLC', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Valley Research', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'facility': 'National Research Institute', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'National Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91763', 'city': 'Montclair', 'state': 'California', 'country': 'United States', 'facility': 'Catalina Research Institute, LLC', 'geoPoint': {'lat': 34.07751, 'lon': -117.68978}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Valley Clinical Trials, Inc.', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '94607', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Research Partners, LLC', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '91402', 'city': 'Panorama City', 'state': 'California', 'country': 'United States', 'facility': 'National Research Institute', 'geoPoint': {'lat': 34.22473, 'lon': -118.44981}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Sierra Clinical Research', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91321', 'city': 'Santa Clarita', 'state': 'California', 'country': 'United States', 'facility': 'Care Access Research', 'geoPoint': {'lat': 34.39166, 'lon': -118.54259}}, {'zip': '91978', 'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'facility': 'Encompass Clinical Research', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'University Clinical Investigators, Inc.', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Chase Medical Research, LLC', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '33024', 'city': 'Cooper City', 'state': 'Florida', 'country': 'United States', 'facility': 'ALL Medical Research, LLC', 'geoPoint': {'lat': 26.05731, 'lon': -80.27172}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of South Florida', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Research Group, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'New Horizon Research Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32765', 'city': 'Oviedo', 'state': 'Florida', 'country': 'United States', 'facility': 'Oviedo Medical Research', 'geoPoint': {'lat': 28.67, 'lon': -81.20812}}, {'zip': '30067', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Urban Family Practice Associates, PC', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '30071', 'city': 'Peachtree Corners', 'state': 'Georgia', 'country': 'United States', 'facility': 'In-Quest Medical Research, LLC- Peachtree Corners', 'geoPoint': {'lat': 33.9701, 'lon': -84.22159}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Pacific Diabetes & Endocrine Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'East West Medical Institute', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '83221', 'city': 'Blackfoot', 'state': 'Idaho', 'country': 'United States', 'facility': 'Elite Clinical Trials LLLP', 'geoPoint': {'lat': 43.19047, 'lon': -112.34498}}, {'zip': '83686', 'city': 'Nampa', 'state': 'Idaho', 'country': 'United States', 'facility': 'Saltzer Medical Group. P.A.', 'geoPoint': {'lat': 43.54072, 'lon': -116.56346}}, {'zip': '62711', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Prairie Education and Research Cooperative', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Synexus/Clinical Research Advantage', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Institute for Clinical Research', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '50265', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iderc, P.L.C.', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '04101', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'InterMed, PA', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '20782', 'city': 'Hyattsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar Health Research Institute', 'geoPoint': {'lat': 38.95594, 'lon': -76.94553}}, {'zip': '02721', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'NECCR PrimaCare Research, LLC', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '48504', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Aa Mrc Llc', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Troy Internal Medicine, PC', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '63005', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinical Research Professionals', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '63303', 'city': 'City of Saint Peters', 'state': 'Missouri', 'country': 'United States', 'facility': 'StudyMetrix Research, LLC', 'geoPoint': {'lat': 38.80033, 'lon': -90.62651}}, {'zip': '59102', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Montana Health Research', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '59901', 'city': 'Kalispell', 'state': 'Montana', 'country': 'United States', 'facility': 'Glacier View Research Institute', 'geoPoint': {'lat': 48.19579, 'lon': -114.31291}}, {'zip': '08611', 'city': 'Trenton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Premier Research', 'geoPoint': {'lat': 40.21705, 'lon': -74.74294}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Manhattan Medical Research', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14787', 'city': 'Westfield', 'state': 'New York', 'country': 'United States', 'facility': 'Great Lakes Medical Research', 'geoPoint': {'lat': 42.32228, 'lon': -79.5781}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Metrolina Internal Medicine, P.A.', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Diabetes & Endocrinology Consultants PC', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Aventiv Research', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73069', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Intend Research', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'IPS Research Company', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97330', 'city': 'Corvallis', 'state': 'Oregon', 'country': 'United States', 'facility': 'The Corvallis Clinic P.C.', 'geoPoint': {'lat': 44.56457, 'lon': -123.26204}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Summit Research Network Inc', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15009', 'city': 'Beaver', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Heritage Valley Medical Group, Inc.', 'geoPoint': {'lat': 40.69534, 'lon': -80.30478}}, {'zip': '19446', 'city': 'Lansdale', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Detweiler Family Medicine', 'geoPoint': {'lat': 40.2415, 'lon': -75.28379}}, {'zip': '15236', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Preferred Primary Care Physicians', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Sudir Bansal M.D. Inc.', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '29461', 'city': 'Moncks Corner', 'state': 'South Carolina', 'country': 'United States', 'facility': 'PMG Research of Charleston, LLC', 'geoPoint': {'lat': 33.19632, 'lon': -80.01429}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Chattanooga Research and Medicine (CHARM)', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas Diabetes Endocrine Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75149', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'Southern Endocrinology and Associates PA', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '78231', 'city': 'Shavano Park', 'state': 'Texas', 'country': 'United States', 'facility': 'Consano Clinical Research', 'geoPoint': {'lat': 29.58495, 'lon': -98.55252}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'facility': 'Martin Diagnostic Clinic', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': '75165', 'city': 'Waxahachie', 'state': 'Texas', 'country': 'United States', 'facility': 'ClinPoint Trials, LLC', 'geoPoint': {'lat': 32.38653, 'lon': -96.84833}}, {'zip': '84010', 'city': 'Bountiful', 'state': 'Utah', 'country': 'United States', 'facility': 'Progressive Clinical Research', 'geoPoint': {'lat': 40.88939, 'lon': -111.88077}}, {'zip': '84405', 'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'facility': 'Advanced Research Institute', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}, {'zip': '20110', 'city': 'Manassas', 'state': 'Virginia', 'country': 'United States', 'facility': 'Manassas Clinical Research Center', 'geoPoint': {'lat': 38.75095, 'lon': -77.47527}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Clinical Research Partners, LLC', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98502', 'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'facility': 'Capital Clincial Research Center', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}, {'zip': '99362', 'city': 'Walla Walla', 'state': 'Washington', 'country': 'United States', 'facility': 'Walla Walla Clinic', 'geoPoint': {'lat': 46.06458, 'lon': -118.34302}}, {'zip': '98801', 'city': 'Wenatchee', 'state': 'Washington', 'country': 'United States', 'facility': 'Wenatchee Valley Hospital & Clinics', 'geoPoint': {'lat': 47.42346, 'lon': -120.31035}}, {'zip': '54303', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Prevea Clinic, Inc', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '1405', 'city': 'Caba', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Centro Medico CICEMO'}, {'zip': '1425', 'city': 'Caba', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'CEDIC-Centro de Investigaciones Clinicas'}, {'zip': 'C1179AAB', 'city': 'Caba', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigaciones Medicas IMOBA S.R.L.'}, {'zip': 'C1056ABJ', 'city': 'Ciudad Autonoma de Buenos Aire', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Centro de Investigaciones Metabólicas (CINME)'}, {'zip': 'C1425AGC', 'city': 'Ciudad Autonoma de Buenos Aire', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada'}, {'zip': 'C1119ACN', 'city': 'Ciudad Autonoma de', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Centro de Investigacion y Prevencion Cardiovascular (CIPREC)'}, {'zip': 'B7600FZN', 'city': 'Mar del Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto de Investigaciones Clinicas Mar del Plata', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'zip': 'M5501ARP', 'city': 'Godoy Cruz', 'state': 'Mendoza Province', 'country': 'Argentina', 'facility': 'CIPADI', 'geoPoint': {'lat': -32.92533, 'lon': -68.84428}}, {'zip': 'C1430CKE', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'AXISMED SRL - Bioclinica Research Network', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1408', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'CENUDIAB'}, {'zip': 'C1120AAC', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'Centro Médico Viamonte'}, {'zip': 'C1204AAD', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'Instituto Centenario'}, {'zip': 'C1205AAO', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff'}, {'zip': 'C1128AAF', 'city': 'Ciudad Autonoma de Buenos Air', 'country': 'Argentina', 'facility': 'Mautalen Salud e Investigación - Servicio de Endocrinología'}, {'zip': 'X5000EDC', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Instituto Medico Strusberg', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'X5006CBI', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Centro Medico Privado San Vicente Diabetes', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'X5008HHW', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '2000', 'city': 'Stockerau', 'state': 'Lower Austria', 'country': 'Austria', 'facility': 'Landesklinikum Korneuburg-Stockerau, Standort Stockerau', 'geoPoint': {'lat': 48.38333, 'lon': 16.21667}}, {'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Universitätsklinikum Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '8511', 'city': 'Saint Stefan Ob Stainz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Ordination Dr. Evelyn Fließer-Görzer'}, {'zip': '6800', 'city': 'Feldkirch', 'state': 'Vorarlberg', 'country': 'Austria', 'facility': 'VIVIT Institut am LKH Feldkirch', 'geoPoint': {'lat': 47.23306, 'lon': 9.6}}, {'zip': '1030', 'city': 'Vienna', 'country': 'Austria', 'facility': 'KA Rudolfstiftung', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1060', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Zentrum für klinische Studien Dr. Ursula Hanusch GmbH', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'T4N 6V7', 'city': 'Red Deer', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Bailey Clinic', 'geoPoint': {'lat': 52.26682, 'lon': -113.802}}, {'zip': 'L6T 0G1', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Aggarwal and Associates Ltd', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'L4Y 2N8', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'T. Nemtean Medicine Professional Corporation', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'N7T 4X3', 'city': 'Sarnia', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Bluewater Clinical Research Group Inc', 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'zip': 'L0M 1S0', 'city': 'Stayner', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Stayner Medical Clinic', 'geoPoint': {'lat': 44.41833, 'lon': -80.09598}}, {'zip': 'M9V 4B4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Anil K. Gupta Medicine Professional Corporation', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '17562', 'city': 'Palaió Fáliro', 'state': 'Athens', 'country': 'Greece', 'facility': 'Iatriko Palaiou Falirou, Medical Center', 'geoPoint': {'lat': 37.92812, 'lon': 23.70105}}, {'zip': '11527', 'city': 'Ampelokipoi', 'state': 'Attica', 'country': 'Greece', 'facility': 'Laiko General Hospital of Athens', 'geoPoint': {'lat': 37.98911, 'lon': 23.76416}}, {'zip': '11527', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Gen Hospital of Athens G Gennimatas', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '57010', 'city': 'Eksochi', 'state': 'Thessaloniki', 'country': 'Greece', 'facility': 'G.Papanikolaou General Hospital', 'geoPoint': {'lat': 37.57132, 'lon': 23.14693}}, {'zip': '57001', 'city': 'Thermi', 'state': 'Thessaloniki', 'country': 'Greece', 'facility': 'Thermi Clinic', 'geoPoint': {'lat': 40.54712, 'lon': 23.01967}}, {'zip': '11521', 'city': 'Athens', 'country': 'Greece', 'facility': 'Athens Euroclinic', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '41110', 'city': 'Larissa', 'country': 'Greece', 'facility': 'University General Hospital of Larissa', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '54636', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'AHEPA Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '54639', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Ippokrateio General Hospital of Thessaloniki', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '54645', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Euromedica - General Clinic of Thessaloniki', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '6300', 'city': 'Kalocsa', 'state': 'Bács-Kiskun county', 'country': 'Hungary', 'facility': 'Studium Egeszseghaz Kft.', 'geoPoint': {'lat': 46.52981, 'lon': 18.97283}}, {'zip': '4031', 'city': 'Debrecen', 'state': 'Hajdú-Bihar', 'country': 'Hungary', 'facility': 'Kenezy Gyula Korhaz es Rendelointezet', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '8500', 'city': 'Pápa', 'state': 'Veszprém megye', 'country': 'Hungary', 'facility': 'Grof Esterhazy Korhaz es Rendelointezeti Szakrendelo', 'geoPoint': {'lat': 47.33004, 'lon': 17.4674}}, {'zip': '1032', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Szent Margit Rendelointezet', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1089', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'ClinDiab Kft.', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1171', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Strazsahegy Medicina Bt.', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1213', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'TRANTOR 99 Bt.', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '8800', 'city': 'Nagykanizsa', 'country': 'Hungary', 'facility': 'Kanizsai Dorottya Korhaz', 'geoPoint': {'lat': 46.45347, 'lon': 16.99104}}, {'zip': '8900', 'city': 'Zalaegerszeg', 'country': 'Hungary', 'facility': 'Zala Megyei Szent Rafael Korhaz', 'geoPoint': {'lat': 46.83695, 'lon': 16.84401}}, {'zip': '3299001', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Maccabi Diabetes Clinic, Grand Canyon, North District, Haifa', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '3515209', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Linn Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '911201', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '4428164', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '4345204', 'city': 'Raanana', 'country': 'Israel', 'facility': 'Clalit Health Services - Shuali Clinic', 'geoPoint': {'lat': 32.1836, 'lon': 34.87386}}, {'zip': '13100', 'city': 'Safed', 'country': 'Israel', 'facility': 'ZIV Medical Center', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}, {'zip': '3081000', 'city': 'Sakhnin', 'country': 'Israel', 'facility': 'Sakhnin Community Clinic, Clalit Health Services', 'geoPoint': {'lat': 32.86422, 'lon': 35.29707}}, {'zip': '6148002', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Diabetes Medical Center (DMC)', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '6423906', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '50134', 'city': 'Florence', 'state': 'Florence', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '53100', 'city': 'Siena', 'state': 'SI', 'country': 'Italy', 'facility': 'A.O.U. Senese Policlinico Santa Maria alle Scotte', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': '24127', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Papa Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Policlinico Mater Domini', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '66100', 'city': 'Chieti', 'country': 'Italy', 'facility': "Fondazione Universitaria degli Studi G D'Annunzio", 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'zip': '04100', 'city': 'Latina', 'country': 'Italy', 'facility': 'Ospedale Santa Maria Goretti', 'geoPoint': {'lat': 41.46614, 'lon': 12.9043}}, {'zip': '90127', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Policlinico Giaccone', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '37126', 'city': 'Verona', 'country': 'Italy', 'facility': 'Ospedale Civile Maggiore Borgo Trento', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Hospital Univ. Dr. Jose Eleuterio Gonzalez', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '31217', 'city': 'Chihuahua City', 'country': 'Mexico', 'facility': 'Investigacion en Salud y Metabolismo S.C', 'geoPoint': {'lat': 28.63528, 'lon': -106.08889}}, {'zip': '15-351', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'NZOZ ZDROWIE Osteo-Medic', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '15-404', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Poradnia Diabetologiczna SN ZOZ Lege Artis', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '15-445', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'NS ZOZ Osrodek Diabetologiczny " Popula"', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '80-546', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Centrum Badan Klinicznych, PI House', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '40-772', 'city': 'Katowice', 'country': 'Poland', 'facility': 'NZOZ Salvia s.c.', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '31-261', 'city': 'Krakow', 'country': 'Poland', 'facility': 'NZOZ Diab-Endo-Met', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '90-242', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20-333', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Gabinety Terpa', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '20-538', 'city': 'Lublin', 'country': 'Poland', 'facility': 'NZOZ Przychodnia Specjalistyczna MEDICA', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '60-111', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Centrum Medyczne OMEDICA', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '61-655', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Praktyka Lekarska', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '61-853', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Nzoz Neuro - Kard', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '41-709', 'city': 'Ruda Śląska', 'country': 'Poland', 'facility': 'NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek', 'geoPoint': {'lat': 50.2584, 'lon': 18.85632}}, {'zip': '02-507', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Centralny Szpital Kliniczny MSW', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-127', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Regionalna Poradnia Diabetologiczna', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '00717', 'city': 'Ponce', 'state': 'PR', 'country': 'Puerto Rico', 'facility': 'Research and Cardiovascular Corp.', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'zip': '00921', 'city': 'San Juan', 'state': 'PR', 'country': 'Puerto Rico', 'facility': 'Office: Dr. Luis Rivera Colon', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00909', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Clinical Research Puerto Rico, Inc.', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00917', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'GCM Medical Group PSC', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '410159', 'city': 'Oradea', 'state': 'Bihor County', 'country': 'Romania', 'facility': 'S. C. Grandmed S.R.L., Str.', 'geoPoint': {'lat': 47.0458, 'lon': 21.91833}}, {'zip': '905500', 'city': 'Mangalia', 'state': 'Constanța County', 'country': 'Romania', 'facility': 'SC Gama Diamed SRL', 'geoPoint': {'lat': 43.81623, 'lon': 28.57656}}, {'zip': '440055', 'city': 'Satu Mare', 'state': 'Jud Satu-Mare', 'country': 'Romania', 'facility': 'Spitalul Judetean de Urgenta Satu Mare', 'geoPoint': {'lat': 47.79926, 'lon': 22.86255}}, {'zip': '430222', 'city': 'Baia Mare', 'state': 'Maramureş', 'country': 'Romania', 'facility': 'CMI DNBM Dr. Pop Lavinia', 'geoPoint': {'lat': 47.65729, 'lon': 23.56808}}, {'zip': '540098', 'city': 'Târgu Mureş', 'state': 'Mureș County', 'country': 'Romania', 'facility': 'Cosamext SRL', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'zip': '100163', 'city': 'Ploieşti', 'state': 'Prahova', 'country': 'Romania', 'facility': 'SC Diabmed Dr Popescu Alexandrina SRL', 'geoPoint': {'lat': 44.95, 'lon': 26.01667}}, {'zip': '100561', 'city': 'Ploieşti', 'state': 'Prahova', 'country': 'Romania', 'facility': 'SC Dianutrilife Medica SRL', 'geoPoint': {'lat': 44.95, 'lon': 26.01667}}, {'zip': '300456', 'city': 'Timișoara', 'state': 'Timiș County', 'country': 'Romania', 'facility': 'Centrul Medical Dr. Negrisanu', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'zip': '500283', 'city': 'Brasov', 'country': 'Romania', 'facility': 'Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'zip': '010507', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Cabinetul Medical Nicodiab SRL', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '010627', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Easydiet SRL', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '013682', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'SC Nutrilife SRL', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '120203', 'city': 'Buzău', 'country': 'Romania', 'facility': 'SC Medcon SRL', 'geoPoint': {'lat': 45.15, 'lon': 26.83333}}, {'zip': '400349', 'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Centrul Medical Unirea SRL', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '200349', 'city': 'Craiova', 'country': 'Romania', 'facility': 'Cabinet Medical Urodiamed S.R.L.', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '800001', 'city': 'Galati', 'country': 'Romania', 'facility': 'Milena Sante SRL', 'geoPoint': {'lat': 45.43687, 'lon': 28.05028}}, {'zip': '700400', 'city': 'Iași', 'country': 'Romania', 'facility': 'SC Olimpia Med SRL', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '410053', 'city': 'Saratov', 'state': 'Russian Federation', 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '163045', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Arkhangelsk Regional Clinical Hospital', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '163045', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Arkhangelsk the first city clinical hospital', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '344022', 'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'Rostov State Medical University', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'zip': '193257', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Hospital of Saint Martyr Elizabeth', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '198255', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'SPb GUZ "Diagnostic Center #85"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '04012', 'city': 'Košice', 'state': 'Slovak Republic', 'country': 'Slovakia', 'facility': 'Human care s.r.o.', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': '90101', 'city': 'Malacky', 'state': 'Slovak Republic', 'country': 'Slovakia', 'facility': 'MediVet s.r.o.', 'geoPoint': {'lat': 48.43604, 'lon': 17.02188}}, {'zip': '07501', 'city': 'Trebišov', 'state': 'Slovak Republic', 'country': 'Slovakia', 'facility': 'Areteus s.r.o.', 'geoPoint': {'lat': 48.62858, 'lon': 21.71954}}, {'zip': '84102', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Diacrin s.r.o.', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '91501', 'city': 'Nové Mesto nad Váhom', 'country': 'Slovakia', 'facility': 'Noemis, s.r.o.', 'geoPoint': {'lat': 48.75763, 'lon': 17.8309}}, {'zip': '94001', 'city': 'Nové Zámky', 'country': 'Slovakia', 'facility': 'FUNKYSTUFF s.r.o.', 'geoPoint': {'lat': 47.98544, 'lon': 18.16195}}, {'zip': '97101', 'city': 'Prievidza', 'country': 'Slovakia', 'facility': 'MUDr. Jan Culak, s.r.o.', 'geoPoint': {'lat': 48.77446, 'lon': 18.6275}}, {'zip': '02001', 'city': 'Púchov', 'country': 'Slovakia', 'facility': 'DIA-MED CENTRUM s.r.o.', 'geoPoint': {'lat': 49.12494, 'lon': 18.32597}}, {'zip': '04801', 'city': 'Rožňava', 'country': 'Slovakia', 'facility': 'Tatratrial s.r.o.', 'geoPoint': {'lat': 48.66009, 'lon': 20.53758}}, {'zip': '41010', 'city': 'Seville', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Hospital Infanta Luisa', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '07014', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Clinica Juaneda', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Corporació Sanitaria Parc Tauli', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '39011', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Hospital Universitario Marques De Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '28223', 'city': 'Pozuelo de Alarcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Quiron Madrid', 'geoPoint': {'lat': 40.43293, 'lon': -3.81338}}, {'zip': '03004', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Instituto de Ciencias medicas', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '04001', 'city': 'Almería', 'country': 'Spain', 'facility': 'Clinica San Pedro', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'zip': '08022', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Centre Medico Teknon', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '18012', 'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '18014', 'city': 'Granada', 'country': 'Spain', 'facility': 'Virgen de Las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '29006', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Centro Especialidades San Jose Obrero (Barbarela)', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '41003', 'city': 'Seville', 'country': 'Spain', 'facility': 'Clinica Nuevas Tecnologias en Diabetes y Endocrinologia', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41009', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '44002', 'city': 'Teruel', 'country': 'Spain', 'facility': 'Policlinica Galileo', 'geoPoint': {'lat': 40.3456, 'lon': -1.10646}}, {'zip': '40201', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '40705, ROC', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '71004', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Chi-Mei Medical Center', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], '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'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}