Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-27 @ 11:23 PM
Study NCT ID:
NCT04847557
Status:
COMPLETED
Last Update Posted:
2025-08-20
First Post:
2021-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098860', 'term': 'Tirzepatide'}], 'ancestors': [{'id': 'D000067757', 'term': 'Glucagon-Like Peptide-1 Receptor'}, {'id': 'D000067756', 'term': 'Glucagon-Like Peptide Receptors'}, {'id': 'D043562', 'term': 'Receptors, G-Protein-Coupled'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011964', 'term': 'Receptors, Gastrointestinal Hormone'}, {'id': 'D018000', 'term': 'Receptors, Peptide'}]}}, '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': 'Baseline Up To 162 Weeks', 'description': 'All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.', 'eventGroups': [{'id': 'EG000', 'title': 'Tirzepatide - MTD', 'description': 'Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW).', 'otherNumAtRisk': 364, 'deathsNumAtRisk': 364, 'otherNumAffected': 221, 'seriousNumAtRisk': 364, 'deathsNumAffected': 19, 'seriousNumAffected': 96}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received placebo administered SC QW.', 'otherNumAtRisk': 367, 'deathsNumAtRisk': 367, 'otherNumAffected': 137, 'seriousNumAtRisk': 367, 'deathsNumAffected': 15, 'seriousNumAffected': 94}], 'otherEvents': [{'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 19, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 24, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 78, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 27, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 185, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 33, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 30, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 214, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 32, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 71, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 35, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 45, 'numAffected': 41}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 42, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 42, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 81, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 27, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 18, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Heart failure with preserved ejection fraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Paroxysmal atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Myocardial bridging', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diabetic gastroparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Incarcerated inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oesophageal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Peptic ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Varices oesophageal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pacemaker syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Aspergillus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Covid-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hepatitis b', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Septic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Postoperative respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperglycaemic hyperosmolar nonketotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Biliary neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastrointestinal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Invasive breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ovarian adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Papillary renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Plasmacytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Prostatic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tonsil cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Basal ganglia haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Thrombotic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Prosthetic cardiac valve malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bladder stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypertensive nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypertonic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary bladder haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tracheomalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac device implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Coronary angioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Percutaneous coronary intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bleeding varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Distributive shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide - MTD', 'description': 'Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.51', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '12.68', 'spread': '1.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.9', 'ciLowerLimit': '3.3', 'ciUpperLimit': '10.6', 'estimateComment': 'The Hodges-Lehmann estimate for the median difference and 95% CIs was reported.', 'statisticalMethod': 'Stratified Wilcoxon', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified Wilcoxon test used to control for stratification factors of HF decompensation within 12 months of screening,diagnosed T2DM \\& baseline BMI'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The KCCQ is a 23-item, participant self-administered questionnaire that assesses impacts of heart failure "over the past 2 weeks" on the following 7 domains:\n\n* Physical Limitation (6)\n* Symptom Stability (1)\n* Symptom Frequency (4)\n* Symptom Burden (3)\n* Self-Efficacy (2)\n* Quality of Life (3)\n* Social Limitation (4)\n\nEach of the 23 individual items are answered on Likert scales of varying lengths (5, 6, or 7-point scales).\n\nKCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are obtained by averaging the associated individual items and transforming the score to a 0 to 100 range. Higher scores indicate better health status.\n\nLeast Square (LS) mean was determined using ANCOVA model with Baseline + HF Decompensation Within 12 Months of Screening + T2DM Status + Baseline BMI group (\\<35, \\>=35 kg/m2) + Treatment (Type III sum of squares) as variables .', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'PRIMARY', 'title': 'First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide - MTD', 'description': 'Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.41', 'ciUpperLimit': '0.95', 'groupDescription': 'Heart Failure Outcomes', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Up To 160 weeks', 'description': 'Clinical Endpoint Committe confirmed Occurrences of CV outcomes were reported here. HF outcomes consisted of cardiovascular death and HF events.\n\nThe HF events were defined as worsening clinical symptoms or signs related to HF, which are meaningful to the participant and require intensification of treatment characterized by 1 or more of the following:\n\n* hospitalization for heart failure regardless of duration or treatment received\n* use of intravenous drug, usually an intravenous diuretic, but may include intravenous vasodilators or positive inotropic drugs, or\n* augmentation or increase in oral diuretic therapy.', 'unitOfMeasure': 'Number of events', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide - MTD', 'description': 'Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.04', 'spread': '3.81', 'groupId': 'OG000'}, {'value': '10.10', 'spread': '3.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.3', 'ciLowerLimit': '9.9', 'ciUpperLimit': '26.7', 'estimateComment': 'The Hodges-Lehmann estimate for the median difference and 95% CIs was reported.', 'statisticalMethod': 'Stratified Wilcoxon', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified Wilcoxon test used to control for stratification factors of HF decompensation within 12 months of screening,diagnosed T2DM \\& baseline BMI'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Participants performed an exercise capacity assessment using the 6-Minute Walk Test (6MWT) and the distance covered (6MWD) was assessed in meters. The 6MWT was performed indoors on a straight, flat, hard surface that is at least 30 meters in length. The greater distance walked meant better physical capacity.\n\nLS Mean was determined using ANCOVA model with Baseline + HF Decompensation Within 12 Months of Screening + T2DM Status + Baseline BMI group (\\<35, \\>=35 kg/m2) + Treatment (Type III sum of squares) as variables.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable data for this outcome,'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide - MTD', 'description': 'Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.85', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '-2.24', 'spread': '0.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.62', 'ciLowerLimit': '-12.85', 'ciUpperLimit': '-10.38', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Percent change in bodyweight was reported. LS mean was determined using ANCOVA model with Baseline + HF Decompensation Within 12 Months of Screening + T2DM Status + Baseline BMI group (\\<35, \\>=35 kg/m2) + Treatment (Type III sum of squares) as variables.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide - MTD', 'description': 'Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.76', 'spread': '4.47', 'groupId': 'OG000'}, {'value': '-5.88', 'spread': '5.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-34.91', 'ciLowerLimit': '-45.60', 'ciUpperLimit': '-22.17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Percent change from baseline in hsCRP was reported. LS Mean was determined using ANCOVA model with log (actual measurement/baseline) = log (baseline) + HF decompensation within 12 months of screening + T2DM status + baseline BMI group (\\<35, \\>=35 kg/m2) + Treatment (Type III sum of squares) as variables.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Win Percentage of the Hierarchical Composite Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide - MTD', 'description': 'Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.90', 'groupId': 'OG000'}, {'value': '35.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Win Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.63', 'ciLowerLimit': '1.17', 'ciUpperLimit': '2.28', 'estimateComment': 'The win ratio was reported as the measure of treatment effect based on the principle that each participant is compared with every other participant within each stratum in a pair-wise manner that proceeds in a hierarchical fashion.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Up To 160 Weeks', 'description': 'Hierarchical Composite Endpoint included time to all-cause death, number of HF events, time to first HF events, KCCQ-CSS, 6MWD.\n\nThe winner was determined in each pair-wise comparison in the following order:\n\n* A delayed first occurrence of all-cause death\n* If the pair cannot be differentiated based on death, winner has fewer HF events\n* If the pair cannot be differentiated by number of HF events, winner has delayed time to occurrence of first HF event\n* If the pair still cannot be differentiated, winner has a more favorable category for change from baseline in 6MWD\n* If the pair still cannot be differentiated, winner has a more favorable category for change from baseline in KCCQ-CSS\n* Otherwise the pair will be recorded as tied.\n\nReported unit is the total percent of "wins" for each treatment group from performing such a hierarchical comparison across stratification factors in the study.', 'unitOfMeasure': 'Win percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With New York Heart Association (NYHA) Class Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide - MTD', 'description': 'Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.27', 'groupId': 'OG000'}, {'value': '20.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.28', 'ciLowerLimit': '1.53', 'ciUpperLimit': '3.40', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Percentage of participants with NYHA class change at Week 52 was reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participant who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Time to All-Cause Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide - MTD', 'description': 'Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.245', 'ciLowerLimit': '0.633', 'ciUpperLimit': '2.452', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline Up To 160 Weeks', 'description': 'All-cause mortality is death due to any cause. Number of participants with time to all-cause mortality are presented.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Time to First Occurrence of HF Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide - MTD', 'description': 'Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.539', 'ciLowerLimit': '0.342', 'ciUpperLimit': '0.850', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline Up To 160 Weeks', 'description': 'Number of participants with time to first occurrence of HF events are reported.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of HF Events and All-Cause Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide - MTD', 'description': 'Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.46', 'ciUpperLimit': '1.14', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Up To 160 Weeks.', 'description': 'Number of HF events and all-cause death are reported.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Recurrent HF Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide - MTD', 'description': 'Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.37', 'ciUpperLimit': '1.05', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Up To 160 Weeks.', 'description': 'Number of recurrent HF events were reported.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tirzepatide - MTD', 'description': 'Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW) and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or maximum tolerated dose (MTD) tolerated by the participant (5 mg QW or 10 mg QW).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received placebo administered SC QW.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '364'}, {'groupId': 'FG001', 'numSubjects': '367'}]}, {'type': 'Received At Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '364'}, {'groupId': 'FG001', 'numSubjects': '367'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '332'}, {'groupId': 'FG001', 'numSubjects': '331'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'BG000'}, {'value': '367', 'groupId': 'BG001'}, {'value': '731', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tirzepatide - MTD', 'description': 'Participants received a starting dose of 2.5 mg tirzepatide administered SC QW and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or MTD tolerated by the participant (5 mg QW or 10 mg QW).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received placebo administered SC QW.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.50', 'spread': '10.53', 'groupId': 'BG000'}, {'value': '65.00', 'spread': '10.87', 'groupId': 'BG001'}, {'value': '65.20', 'spread': '10.70', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '393', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '338', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '256', 'groupId': 'BG000'}, {'value': '256', 'groupId': 'BG001'}, {'value': '512', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}, {'title': 'China', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-14', 'size': 1282694, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-11T09:05', 'hasProtocol': True}, {'date': '2024-06-26', 'size': 934610, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-11T09:06', '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': 731}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2021-02-26', 'resultsFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2021-04-13', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-08-15', 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)', 'timeFrame': 'Baseline, Week 52', 'description': 'The KCCQ is a 23-item, participant self-administered questionnaire that assesses impacts of heart failure "over the past 2 weeks" on the following 7 domains:\n\n* Physical Limitation (6)\n* Symptom Stability (1)\n* Symptom Frequency (4)\n* Symptom Burden (3)\n* Self-Efficacy (2)\n* Quality of Life (3)\n* Social Limitation (4)\n\nEach of the 23 individual items are answered on Likert scales of varying lengths (5, 6, or 7-point scales).\n\nKCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are obtained by averaging the associated individual items and transforming the score to a 0 to 100 range. Higher scores indicate better health status.\n\nLeast Square (LS) mean was determined using ANCOVA model with Baseline + HF Decompensation Within 12 Months of Screening + T2DM Status + Baseline BMI group (\\<35, \\>=35 kg/m2) + Treatment (Type III sum of squares) as variables .'}, {'measure': 'First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes', 'timeFrame': 'Baseline Up To 160 weeks', 'description': 'Clinical Endpoint Committe confirmed Occurrences of CV outcomes were reported here. HF outcomes consisted of cardiovascular death and HF events.\n\nThe HF events were defined as worsening clinical symptoms or signs related to HF, which are meaningful to the participant and require intensification of treatment characterized by 1 or more of the following:\n\n* hospitalization for heart failure regardless of duration or treatment received\n* use of intravenous drug, usually an intravenous diuretic, but may include intravenous vasodilators or positive inotropic drugs, or\n* augmentation or increase in oral diuretic therapy.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD)', 'timeFrame': 'Baseline, Week 52', 'description': 'Participants performed an exercise capacity assessment using the 6-Minute Walk Test (6MWT) and the distance covered (6MWD) was assessed in meters. The 6MWT was performed indoors on a straight, flat, hard surface that is at least 30 meters in length. The greater distance walked meant better physical capacity.\n\nLS Mean was determined using ANCOVA model with Baseline + HF Decompensation Within 12 Months of Screening + T2DM Status + Baseline BMI group (\\<35, \\>=35 kg/m2) + Treatment (Type III sum of squares) as variables.'}, {'measure': 'Percent Change From Baseline in Body Weight', 'timeFrame': 'Baseline, Week 52', 'description': 'Percent change in bodyweight was reported. LS mean was determined using ANCOVA model with Baseline + HF Decompensation Within 12 Months of Screening + T2DM Status + Baseline BMI group (\\<35, \\>=35 kg/m2) + Treatment (Type III sum of squares) as variables.'}, {'measure': 'Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)', 'timeFrame': 'Baseline, Week 52', 'description': 'Percent change from baseline in hsCRP was reported. LS Mean was determined using ANCOVA model with log (actual measurement/baseline) = log (baseline) + HF decompensation within 12 months of screening + T2DM status + baseline BMI group (\\<35, \\>=35 kg/m2) + Treatment (Type III sum of squares) as variables.'}, {'measure': 'Win Percentage of the Hierarchical Composite Endpoint', 'timeFrame': 'Baseline Up To 160 Weeks', 'description': 'Hierarchical Composite Endpoint included time to all-cause death, number of HF events, time to first HF events, KCCQ-CSS, 6MWD.\n\nThe winner was determined in each pair-wise comparison in the following order:\n\n* A delayed first occurrence of all-cause death\n* If the pair cannot be differentiated based on death, winner has fewer HF events\n* If the pair cannot be differentiated by number of HF events, winner has delayed time to occurrence of first HF event\n* If the pair still cannot be differentiated, winner has a more favorable category for change from baseline in 6MWD\n* If the pair still cannot be differentiated, winner has a more favorable category for change from baseline in KCCQ-CSS\n* Otherwise the pair will be recorded as tied.\n\nReported unit is the total percent of "wins" for each treatment group from performing such a hierarchical comparison across stratification factors in the study.'}, {'measure': 'Percentage of Participants With New York Heart Association (NYHA) Class Change', 'timeFrame': 'Week 52', 'description': 'Percentage of participants with NYHA class change at Week 52 was reported.'}, {'measure': 'Number of Participants With Time to All-Cause Death', 'timeFrame': 'Baseline Up To 160 Weeks', 'description': 'All-cause mortality is death due to any cause. Number of participants with time to all-cause mortality are presented.'}, {'measure': 'Number of Participants With Time to First Occurrence of HF Events', 'timeFrame': 'Baseline Up To 160 Weeks', 'description': 'Number of participants with time to first occurrence of HF events are reported.'}, {'measure': 'Number of HF Events and All-Cause Death', 'timeFrame': 'Baseline Up To 160 Weeks.', 'description': 'Number of HF events and all-cause death are reported.'}, {'measure': 'Number of Recurrent HF Events', 'timeFrame': 'Baseline Up To 160 Weeks.', 'description': 'Number of recurrent HF events were reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure with Preserved Ejection Fraction (HFpEF)'], 'conditions': ['Obesity', 'Heart Failure With Preserved Ejection Fraction (HFpEF)']}, 'referencesModule': {'references': [{'pmid': '40903131', 'type': 'DERIVED', 'citation': 'Packer M, Zile MR, Kramer CM, DiMaria JM, Baum SJ, Litwin SE, Murakami M, Zhou C, Ou Y, Koeneman L, Borlaug BA; SUMMIT Trial Study Group. Influence of Type 2 Diabetes on the Effects of Tirzepatide in Patients With Heart Failure and a Preserved Ejection Fraction With Obesity: A Prespecified Stratification-Based Analysis. J Am Coll Cardiol. 2025 Sep 9;86(10):696-707. doi: 10.1016/j.jacc.2025.06.058.'}, {'pmid': '40701669', 'type': 'DERIVED', 'citation': 'Borlaug BA, Zile MR, Kramer CM, Ye W, Ou Y, Hurt K, Murakami M, Packer M; SUMMIT Trial Study Group. Impact of Body Mass Index, Central Adiposity, and Weight Loss on the Benefits of Tirzepatide in HFpEF: The SUMMIT Trial. J Am Coll Cardiol. 2025 Jul 29;86(4):242-255. doi: 10.1016/j.jacc.2025.04.059.'}, {'pmid': '40162940', 'type': 'DERIVED', 'citation': 'Packer M, Zile MR, Kramer CM, Murakami M, Ou Y, Borlaug BA; SUMMIT Trial Study Group. Interplay of Chronic Kidney Disease and the Effects of Tirzepatide in Patients With Heart Failure, Preserved Ejection Fraction, and Obesity: The SUMMIT Trial. J Am Coll Cardiol. 2025 May 13;85(18):1721-1735. doi: 10.1016/j.jacc.2025.03.009. Epub 2025 Mar 31.'}, {'pmid': '39566869', 'type': 'DERIVED', 'citation': 'Kramer CM, Borlaug BA, Zile MR, Ruff D, DiMaria JM, Menon V, Ou Y, Zarante AM, Hurt KC, Murakami M, Packer M; SUMMIT Trial Study Group. Tirzepatide Reduces LV Mass and Paracardiac Adipose Tissue in Obesity-Related Heart Failure: SUMMIT CMR Substudy. J Am Coll Cardiol. 2025 Feb 25;85(7):699-706. doi: 10.1016/j.jacc.2024.11.001. Epub 2024 Nov 18.'}, {'pmid': '39556714', 'type': 'DERIVED', 'citation': 'Zile MR, Borlaug BA, Kramer CM, Baum SJ, Litwin SE, Menon V, Ou Y, Weerakkody GJ, Hurt KC, Kanu C, Murakami M, Packer M; SUMMIT Trial Study Group. Effects of Tirzepatide on the Clinical Trajectory of Patients With Heart Failure, Preserved Ejection Fraction, and Obesity. Circulation. 2025 Mar 11;151(10):656-668. doi: 10.1161/CIRCULATIONAHA.124.072679. Epub 2024 Nov 18.'}, {'pmid': '39555826', 'type': 'DERIVED', 'citation': 'Packer M, Zile MR, Kramer CM, Baum SJ, Litwin SE, Menon V, Ge J, Weerakkody GJ, Ou Y, Bunck MC, Hurt KC, Murakami M, Borlaug BA; SUMMIT Trial Study Group. Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity. N Engl J Med. 2025 Jan 30;392(5):427-437. doi: 10.1056/NEJMoa2410027. Epub 2024 Nov 16.'}, {'pmid': '39551891', 'type': 'DERIVED', 'citation': 'Borlaug BA, Zile MR, Kramer CM, Baum SJ, Hurt K, Litwin SE, Murakami M, Ou Y, Upadhyay N, Packer M. Effects of tirzepatide on circulatory overload and end-organ damage in heart failure with preserved ejection fraction and obesity: a secondary analysis of the SUMMIT trial. Nat Med. 2025 Feb;31(2):544-551. doi: 10.1038/s41591-024-03374-z. Epub 2024 Nov 17.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/4deAJHqkMfFYm9JjtgeqTl', 'label': 'A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.', 'detailedDescription': "The study will continue until approximately 52 weeks after the last participant is randomized. The maximum duration of an individual's participation is estimated to be \\~120 weeks and will depend on duration of study enrollment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of stable heart failure (NYHA class II-IV) and left ventricular ejection fraction (LVEF) ≥50%\n* Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide) \\> 200 picogram/milliliter (pg/ml) for participants without atrial fibrillation (AF), or \\>600 pg/ml for participants with AF, Structural heart disease (Left atrial enlargement) or Elevated left ventricular filling pressure\n* Estimated glomerular filtration rate (eGFR) \\<70 milliliter (ml)/minute (min)/1.73m² at screening, or HF decompensation within 12 months of screening,\n* Stable dose of heart failure medications within 4 weeks of screening\n* Body mass index (BMI) ≥30 kilograms per meter squared (kg/m²)\n* 6MWD 100-425 meters\n* KCCQ CSS ≤80\n\nExclusion Criteria:\n\n* Have had a major cardiovascular event within the last 90 days of screening\n* Have had acute decompensated heart failure within 4 weeks of screening\n* Have non cardiac causes of functional impairment such as pulmonary arterial hypertension (PAH), severe chronic obstructive pulmonary disease (COPD), anemia, thyroid disease, musculoskeletal disease or orthopedic conditions\n* Presence of cardiac amyloidosis, cardiac accumulation disease, cardiomyopathy and severe valvular heart disease\n* HbA1c ≥9.5% or uncontrolled diabetes\n* History of proliferative diabetic retinopathy or diabetic maculopathy\n* Have a history of pancreatitis\n* eGFR \\<15 mL/min/1.73 m² or requiring dialysis at screening'}, 'identificationModule': {'nctId': 'NCT04847557', 'briefTitle': 'A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)', 'orgStudyIdInfo': {'id': '17757'}, 'secondaryIdInfos': [{'id': 'I8F-MC-GPID', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tirzepatide', 'description': 'Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW) and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or maximum tolerated dose (MTD) tolerated by the participant (5 mg QW or 10 mg QW).', 'interventionNames': ['Drug: Tirzepatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo administered SC QW.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Tirzepatide', 'type': 'DRUG', 'otherNames': ['LY3298176'], 'description': 'Administered SC', 'armGroupLabels': ['Tirzepatide']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Heart Center Research', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Westside Medical Associates of Los Angeles', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91723', 'city': 'Covina', 'state': 'California', 'country': 'United States', 'facility': 'Valley Clinical Trials, Inc.', 'geoPoint': {'lat': 34.09001, 'lon': -117.89034}}, {'zip': '91344', 'city': 'Granada Hills', 'state': 'California', 'country': 'United States', 'facility': 'Amicis Research Center', 'geoPoint': {'lat': 34.26472, 'lon': -118.52314}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego - La Jolla', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Valley Clinical Trials, Inc.', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'The Lundquist Institute', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80120', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'South Denver Cardiology Associates', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '06905', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Cardiology Associates of Fairfield County, P.C.', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '33434', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Excel Medical Clinical Trials', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clearwater Cardiovascular & Interventional Consultants M.D., P.A.', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33777', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'Clearwater Cardiovascular & Interventional Consultants M.D., P.A.', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Infinite Clinical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Ocala Caridovascular Research', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '34695', 'city': 'Safety Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'Clearwater Cardiovascular & Interventional Consultants M.D., P.A.', 'geoPoint': {'lat': 27.99085, 'lon': -82.69316}}, {'zip': '32086', 'city': 'Saint Augustine', 'state': 'Florida', 'country': 'United States', 'facility': 'East Coast Institute for Research - St. Augustine', 'geoPoint': {'lat': 29.89469, 'lon': -81.31452}}, {'zip': '30310', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Morehouse School Of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '83712', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': "St. Luke's Boise Medical Center", 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwest Heart Clinical Research', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '61636', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Methodist Medical Center of Illinois', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '46321', 'city': 'Munster', 'state': 'Indiana', 'country': 'United States', 'facility': 'Cardiovascular Research of Northwest Indiana', 'geoPoint': {'lat': 41.56448, 'lon': -87.51254}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Midwest Heart & Vascular Specialists', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '71111', 'city': 'Bossier City', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Grace Research - Bossier', 'geoPoint': {'lat': 32.51599, 'lon': -93.73212}}, {'zip': '70403', 'city': 'Hammond', 'state': 'Louisiana', 'country': 'United States', 'facility': 'The Heart Clinic - Hammond', 'geoPoint': {'lat': 30.50463, 'lon': -90.46293}}, {'zip': '71105', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Grace Research - Shreveport', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21229', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Cardiovascular Specialists', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48708', 'city': 'Bay City', 'state': 'Michigan', 'country': 'United States', 'facility': 'McLaren Bay Region', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'zip': '63136', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis Heart and Vascular, P.C.', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Palm Research Center Tenaya', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08035', 'city': 'Haddon Heights', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Heart House', 'geoPoint': {'lat': 39.87734, 'lon': -75.06462}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Lovelace Medical Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Erie County Medical Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '14621', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester General Hospital', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '12866', 'city': 'Saratoga Springs', 'state': 'New York', 'country': 'United States', 'facility': 'Saratoga Cardiology Associates', 'geoPoint': {'lat': 43.08313, 'lon': -73.78457}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '28277', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OnSite Clinical Solutions', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44710', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Aultman Hospital Research', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '43302', 'city': 'Marion', 'state': 'Ohio', 'country': 'United States', 'facility': 'Rama Research', 'geoPoint': {'lat': 40.58867, 'lon': -83.12852}}, {'zip': '73102', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Hightower Clinical Trial Services', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97123', 'city': 'Hillsboro', 'state': 'Oregon', 'country': 'United States', 'facility': 'Hillsboro Cardiology', 'geoPoint': {'lat': 45.52289, 'lon': -122.98983}}, {'zip': '17011', 'city': 'Camp Hill', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Capital Area Research, LLC', 'geoPoint': {'lat': 40.23981, 'lon': -76.91997}}, {'zip': '18901', 'city': 'Doylestown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Doylestown Hospital', 'geoPoint': {'lat': 40.31011, 'lon': -75.12989}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Clinical Trials', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Monument Health Rapid City Hospital', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Stern Cardiovascular Foundation', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '38301', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Apex Research Foundation', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '77701', 'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'facility': 'DiscoveResearch', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75069', 'city': 'McKinney', 'state': 'Texas', 'country': 'United States', 'facility': 'North Dallas Research Associates', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': '75092', 'city': 'Sherman', 'state': 'Texas', 'country': 'United States', 'facility': 'Sherman Clinical Research', 'geoPoint': {'lat': 33.63566, 'lon': -96.60888}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'facility': 'Northwest Houston Heart Center', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '98372', 'city': 'Puyallup', 'state': 'Washington', 'country': 'United States', 'facility': 'MultiCare Good Samaritan Hospital', 'geoPoint': {'lat': 47.18538, 'lon': -122.2929}}, {'zip': '1704', 'city': 'Ramos Mejía', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'DIM Clínica Privada', 'geoPoint': {'lat': -34.6551, 'lon': -58.55318}}, {'zip': '2900', 'city': 'San Nicolás de los Arroyos', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Go Centro Medico San Nicolás', 'geoPoint': {'lat': -33.33425, 'lon': -60.2108}}, {'zip': '1405', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Instituto Médico Especializado (IME)', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1128AAF', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Mautalen Salud e Investigación', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1425AGC', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1027AAP', 'city': 'Ciudad Autónoma de Buenos Aire', 'state': 'Buenos Air', 'country': 'Argentina', 'facility': 'Centro de Investigaciones Metabólicas (CINME)'}, {'zip': 'C1061AAS', 'city': 'Buenos Aires', 'state': 'Ciudad Autónoma de Buenos Aire', 'country': 'Argentina', 'facility': 'CIPREC', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '5800', 'city': 'Río Cuarto', 'state': 'Córdoba Province', 'country': 'Argentina', 'facility': 'Instituto Médico Río Cuarto', 'geoPoint': {'lat': -33.13044, 'lon': -64.35272}}, {'zip': 'S2000CVD', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Instituto de Investigaciones Clinicas Rosario', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '1407', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'CEMEDIC', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1426', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Fundación Respirar', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '3400', 'city': 'Corrientes', 'country': 'Argentina', 'facility': 'Instituto de Cardiología "Juana F. Cabral"', 'geoPoint': {'lat': -27.46784, 'lon': -58.8344}}, {'zip': 'X5002HWE', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '3600', 'city': 'Formosa', 'country': 'Argentina', 'facility': 'Hospital de Alta Complejidad "Pte. Juan Domingo Perón"', 'geoPoint': {'lat': -26.18489, 'lon': -58.17313}}, {'zip': '4406', 'city': 'Salta', 'country': 'Argentina', 'facility': 'Centro Cardiovascular Salta', 'geoPoint': {'lat': -24.80645, 'lon': -65.41999}}, {'zip': '5700', 'city': 'San Luis', 'country': 'Argentina', 'facility': 'Instituto Cardiovascular San Luis', 'geoPoint': {'lat': -33.2914, 'lon': -66.32467}}, {'zip': '3000', 'city': 'Santa Fe', 'country': 'Argentina', 'facility': 'Centro de Investigaciones Clinicas del Litoral', 'geoPoint': {'lat': -31.64881, 'lon': -60.70868}}, {'zip': '74605-020', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Universidade Federal de Goias', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '83430-000', 'city': 'Campina Grande do Sul', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Angelina Caron', 'geoPoint': {'lat': -25.30556, 'lon': -49.05528}}, {'zip': '49055-530', 'city': 'Aracaju', 'state': 'Sergipe', 'country': 'Brazil', 'facility': 'Centro de Pesquisa Clinica do Coracao', 'geoPoint': {'lat': -10.91111, 'lon': -37.07167}}, {'zip': '13034-685', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Centro de Pesquisa Sao Lucas', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '13060-080', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto de Pesquisa clinica de Campinas', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '13092133', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Loema Instituto de Pesquisa Clinica', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '14026-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'CAPED Centro Avancado Pesquisa e Diagnostica', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '09080-110', 'city': 'Santo André', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Pesquisare Saude', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'zip': '15090000', 'city': 'São José do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Fundação Faculdade Regional de Medicina de São José do Rio Preto', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}, {'zip': '22241-180', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'IBPClin - Instituto Brasil de Pesquisa Clínica', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '04266-010', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'CEPIC - Centro Paulista de Investigação Clínica', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '730030', 'city': 'Lanzhou', 'state': 'Gansu', 'country': 'China', 'facility': 'Lanzhou university second hospital', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '150001', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'The First Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan University Medical College - Hubei Zhongshan Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Third Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '014010', 'city': 'Baotou', 'state': 'Inner Mongolia', 'country': 'China', 'facility': '1st Hospital affiliate to Baotou medical college', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210011', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '330006', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '337055', 'city': 'Pingxiang', 'state': 'Jiangxi', 'country': 'China', 'facility': "Jiangxi Pingxiang People's Hospital", 'geoPoint': {'lat': 27.61672, 'lon': 113.85353}}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': "Jilin Province People's Hospital", 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '130033', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'China-Japan Union Hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '116000', 'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'The first affiliated hospital of dalian medical university', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'zip': '110000', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': "The People's Hospital of Liaoning Province", 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': "The First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '250013', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Jinan Central Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital,Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital Affiliated Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '830054', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '380060', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'CIMS Hospital - Care Institute of Medical Sciences', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '122018', 'city': 'Gurugramam', 'state': 'Haryana', 'country': 'India', 'facility': 'Medanta The Medicity'}, {'zip': '560099', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Narayana Institute of Cardiac Sciences', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '400012', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '440009', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Government Medical College And Hospital - Nagpur', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '440015', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Central India Cardiology and Research Institute', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '422005', 'city': 'Nashik', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Vijan Hospital & Research Centre', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'zip': '110002', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'G.B. Pant Institute of Postgraduate Medical Education & Research', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '110062', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Batra Hospital and Medical Research Centre', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '500032', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'AIG Hospitals', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '4428164', 'city': 'Kfar Saba', 'state': 'Central District', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'city': 'Petah Tikva', 'state': 'Central District', 'country': 'Israel', 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '5262100', 'city': 'Ramat Gan', 'state': 'Central District', 'country': 'Israel', 'facility': 'Sheba Medical Center'}, {'zip': '7610001', 'city': 'Rehovot', 'state': 'Central District', 'country': 'Israel', 'facility': 'Kaplan Medical Center', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'zip': '9013102', 'city': 'Jerusalem', 'state': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '9112001', 'city': 'Jerusalem', 'state': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '3810101', 'city': 'Hadera', 'state': 'Northern District', 'country': 'Israel', 'facility': 'Hillel Yaffe Medical Center'}, {'zip': '3109601', 'city': 'Haifa', 'state': 'Northern District', 'country': 'Israel', 'facility': 'Rambam Health Care Campus'}, {'zip': '2210001', 'city': 'Nahariya', 'state': 'Northern District', 'country': 'Israel', 'facility': 'Galilee Medical Center', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}, {'zip': '7830604', 'city': 'Ashkelon', 'state': 'Southern District', 'country': 'Israel', 'facility': 'Barzilai Medical Center', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}, {'zip': '6423906', 'city': 'Tel Aviv', 'state': 'Tell Abīb', 'country': 'Israel', 'facility': 'Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '27000', 'city': 'Torreón', 'state': 'Coahuila', 'country': 'Mexico', 'facility': 'CIMAB SA de CV', 'geoPoint': {'lat': 25.54389, 'lon': -103.41898}}, {'zip': '44670', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Virgen Cardiovascular Research SC', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '64060', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Cardiolink Clin Trials', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '66460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Hospital Universitario "Dr. Jose Eleuterio Gonzalez"', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '20230', 'city': 'Aguascalientes', 'country': 'Mexico', 'facility': 'Fundación Cardiovascular de Aguascalientes A.C.', 'geoPoint': {'lat': 21.88262, 'lon': -102.2843}}, {'zip': '20230', 'city': 'Aguascalientes', 'country': 'Mexico', 'facility': 'Hospital Cardiologica Aguescalientes', 'geoPoint': {'lat': 21.88262, 'lon': -102.2843}}, {'zip': '76000', 'city': 'Querétaro', 'country': 'Mexico', 'facility': 'Centro de Estudios Clínicos de Querétaro (CECLIQ)', 'geoPoint': {'lat': 15.83752, 'lon': -92.75774}}, {'zip': '00956', 'city': 'Bayamón', 'country': 'Puerto Rico', 'facility': 'Clinical Research Center - Universidad Central del Caribe (CRC - UCC)', 'geoPoint': {'lat': 18.39856, 'lon': -66.15572}}, {'zip': '00717', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'Research and Cardiovascular Corp.', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'zip': '153012', 'city': 'Ivanovo', 'state': 'Ivanovo Oblast', 'country': 'Russia', 'facility': 'Ivanovo Regional Healthcare Institution Cardiology Dispensary', 'geoPoint': {'lat': 56.99988, 'lon': 40.97257}}, {'zip': '121552', 'city': 'Moscow', 'state': 'Moscow', 'country': 'Russia', 'facility': 'Russian Cardiology Research and Production Complex', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '125993', 'city': 'Moscow', 'state': 'Moscow', 'country': 'Russia', 'facility': 'Russian Medical Academy of Postgraduate Education', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '390026', 'city': 'Ryazan', 'state': 'Ryazan Oblast', 'country': 'Russia', 'facility': 'Ryazan Regional Clinical Cardiological Dispensary', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '199226', 'city': 'Saint Petersburg', 'state': 'Sankt-Peterburg', 'country': 'Russia', 'facility': 'Astarta Clinic', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '426063', 'city': 'Izhevsk', 'state': 'Udmurtiya Republic', 'country': 'Russia', 'facility': 'Izhevsk City Clinical Hospital Number 9', 'geoPoint': {'lat': 56.85225, 'lon': 53.19862}}, {'zip': '402', 'city': 'Taichung', 'state': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '300', 'city': 'Hsinchu', 'country': 'Taiwan', 'facility': 'Mackay Memorial Hospital-Hsinchu', 'geoPoint': {'lat': 24.80361, 'lon': 120.96861}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '110', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung Medical Foundation-Linkou Branch', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], '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': 'http://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 European (EU), whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', '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'}}}}