Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2026-01-02 @ 7:36 AM
Study NCT ID:
NCT05412004
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2022-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': '800-459-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to Follow-up (Up To 56 Weeks)', 'description': 'All randomized participants who are exposed to at least 1 dose of study intervention. As per the prespecified statistical analysis plan, adverse events were analyzed as per the treatment regimen. Gender-specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Tirzepatide MTD_GPI1', 'description': 'Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 91, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Placebo_GPI1', 'description': 'Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 91, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Tirzepatide MTD_GPI2', 'description': 'Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 98, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Placebo_GPI2', 'description': 'Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 82, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Anaemia macrocytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Macrocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sinus arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Autoimmune thyroid disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vitreous degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': "Barrett's oesophagus", 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Colon dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 69, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 56, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 15, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Erosive oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 26, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastrointestinal hypermotility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Malocclusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 59, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 58, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pelvic floor dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Salivary gland cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 34, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Administration site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Application site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 22, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 70, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 44, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Injection site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Local reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Temperature intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gallbladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Conjunctivitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Conjunctivitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Epstein-barr virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fungal foot infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Helicobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 24, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Parasitic gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pseudomembranous colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bone contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Breast injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Epicondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Eye contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Iatrogenic injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Injection related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nail avulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Soft tissue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Spinal column injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Viiith nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Albumin urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood bicarbonate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood calcitonin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood osmolarity decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood pressure measurement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood testosterone decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cardiac murmur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Coronavirus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Creatinine urine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Electrocardiogram t wave inversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lipids abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Mean cell volume increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Occult blood positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pancreatic enzymes increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sars-cov-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vitamin d decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Glucose tolerance impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vitamin d deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Extremity contracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Muscle contracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Muscle tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Plantar fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sacroiliac joint dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tendon disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Torticollis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Trigger finger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vertebral foraminal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Adrenal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Benign neoplasm of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Colorectal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Enchondromatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Melanocytic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Neoplasm skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Seborrhoeic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Carotid arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypotonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ophthalmic migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Taste disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Device physical property issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bruxism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rapid eye movement sleep behaviour disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diabetic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Glomerulonephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertonic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Microalbuminuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cervical cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cervical polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diaphragmatic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Paranasal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Snoring', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tonsillar inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vasomotor rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Actinic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hand dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pigmentation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sebaceous hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cochlea implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fascia release', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Intraocular lens implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Phlebectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ureteral stent insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Aortic occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Internal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gallbladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Loose body in joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Clear cell renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tonsil cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Mood swings', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abnormal uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Asthmatic crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nephrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Apnea-Hypopnea Index (AHI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide MTD_GPI1', 'description': 'Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo_GPI1', 'description': 'Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.'}, {'id': 'OG002', 'title': 'Tirzepatide MTD_GPI2', 'description': 'Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG003', 'title': 'Placebo_GPI2', 'description': 'Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.25', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '-5.25', 'spread': '2.11', 'groupId': 'OG001'}, {'value': '-29.27', 'spread': '1.99', 'groupId': 'OG002'}, {'value': '-5.51', 'spread': '2.21', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.01', 'ciLowerLimit': '-25.82', 'ciUpperLimit': '-14.20', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.77', 'ciLowerLimit': '-29.61', 'ciUpperLimit': '-17.93', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'AHI, Apnea-Hypopnea Index, is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO₂) by at least 4%. AHI values are categorized as 5-15 events/hr = mild; 15-\\<30 events/hr = moderate; and ≥ 30 events/hr = severe. a significant reduction in values indicates a positive outcome.', 'unitOfMeasure': 'events per hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apnea-Hypopnea Index (AHI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide MTD_GPI1', 'description': 'Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo_GPI1', 'description': 'Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.'}, {'id': 'OG002', 'title': 'Tirzepatide MTD_GPI2', 'description': 'Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG003', 'title': 'Placebo_GPI2', 'description': 'Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-50.68', 'spread': '5.90', 'groupId': 'OG000'}, {'value': '-3.03', 'spread': '7.07', 'groupId': 'OG001'}, {'value': '-58.72', 'spread': '5.28', 'groupId': 'OG002'}, {'value': '-2.50', 'spread': '6.95', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47.65', 'ciLowerLimit': '-65.76', 'ciUpperLimit': '-29.55', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-56.21', 'ciLowerLimit': '-73.73', 'ciUpperLimit': '-38.70', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Percent Change From Baseline in AHI was evaluated.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥50% AHI Reduction From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide MTD_GPI1', 'description': 'Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo_GPI1', 'description': 'Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.'}, {'id': 'OG002', 'title': 'Tirzepatide MTD_GPI2', 'description': 'Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG003', 'title': 'Placebo_GPI2', 'description': 'Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.22', 'groupId': 'OG000'}, {'value': '18.96', 'groupId': 'OG001'}, {'value': '72.40', 'groupId': 'OG002'}, {'value': '23.25', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.77', 'ciLowerLimit': '30.76', 'ciUpperLimit': '54.79', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '48.60', 'ciLowerLimit': '36.55', 'ciUpperLimit': '60.65', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Percentage of participants achieving ≥50% AHI reduction from baseline to Week 52 was evaluated.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide MTD_GPI1', 'description': 'Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo_GPI1', 'description': 'Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.'}, {'id': 'OG002', 'title': 'Tirzepatide MTD_GPI2', 'description': 'Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG003', 'title': 'Placebo_GPI2', 'description': 'Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.17', 'groupId': 'OG000'}, {'value': '15.88', 'groupId': 'OG001'}, {'value': '50.24', 'groupId': 'OG002'}, {'value': '14.33', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.74', 'ciLowerLimit': '18.27', 'ciUpperLimit': '39.22', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.22', 'ciLowerLimit': '22.12', 'ciUpperLimit': '44.31', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'The percentage of participants with OSA remission (AHI \\<5 events per hour of sleep) or with mild OSA without excessive daytime sleepiness (AHI 5-14 events per hour of sleep with ESS ≤10) at Week 52 was evaluated. The ESS is used to assess improvements in excessive daytime sleepiness from baseline to Week 52. The ESS is an 8-item, participant-completed measure that asks the participant to rate, on a scale of 0 (no chance of dozing) to 3 (high chance of dozing), their usual chances of dozing in 8 different daytime situations, with a recall period of "in recent times." The ESS total score is the sum of the 8-item scores and ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% Min/Hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide MTD_GPI1', 'description': 'Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo_GPI1', 'description': 'Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.'}, {'id': 'OG002', 'title': 'Tirzepatide MTD_GPI2', 'description': 'Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG003', 'title': 'Placebo_GPI2', 'description': 'Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-95.19', 'spread': '4.081', 'groupId': 'OG000'}, {'value': '-25.07', 'spread': '9.804', 'groupId': 'OG001'}, {'value': '-102.98', 'spread': '3.758', 'groupId': 'OG002'}, {'value': '-41.69', 'spread': '11.313', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-70.13', 'ciLowerLimit': '-90.94', 'ciUpperLimit': '-49.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.619', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-61.29', 'ciLowerLimit': '-84.66', 'ciUpperLimit': '-37.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.921', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'SASHB was determined by measuring the respiratory event-associated area under the curve for oxygen desaturation from pre-event baseline and represents the cumulative burden of intermittent hypoxia caused by OSA-related sleep-disordered breathing at sleep.', 'unitOfMeasure': '%.min/hr', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a (PROMIS SRI) and PROMIS Short Form Sleep Disturbance 8b (PROMIS SD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide MTD_GPI1', 'description': 'Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo_GPI1', 'description': 'Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.'}, {'id': 'OG002', 'title': 'Tirzepatide MTD_GPI2', 'description': 'Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG003', 'title': 'Placebo_GPI2', 'description': 'Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.'}], 'classes': [{'title': 'Sleep Disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.47', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '-2.44', 'spread': '0.70', 'groupId': 'OG001'}, {'value': '-6.98', 'spread': '0.82', 'groupId': 'OG002'}, {'value': '-3.08', 'spread': '0.88', 'groupId': 'OG003'}]}]}, {'title': 'Sleep-Related Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.57', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-3.13', 'spread': '0.80', 'groupId': 'OG001'}, {'value': '-8.18', 'spread': '0.95', 'groupId': 'OG002'}, {'value': '-3.91', 'spread': '1.03', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.03', 'ciLowerLimit': '-3.95', 'ciUpperLimit': '-0.12', 'groupDescription': 'Sleep Disturbance', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.43', 'ciLowerLimit': '-5.69', 'ciUpperLimit': '-1.17', 'groupDescription': 'Sleep Related Impairment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.90', 'ciLowerLimit': '-6.21', 'ciUpperLimit': '-1.58', 'groupDescription': 'Sleep Disturbance', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.'}, {'pValue': '0.002', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.26', 'ciLowerLimit': '-6.97', 'ciUpperLimit': '-1.56', 'groupDescription': 'Sleep-Related Impairment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'PROMIS SRI consists of 8 items that assess self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and perceived functional impairments associated with sleep problems. PROMIS SRI has a recall period of "in the past 7 days" and each item is rated on a 5-point scale from "not at all" to "very much." PROMIS SD consists of 8 items that assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. PROMIS SD has a recall period of "in the past 7 days" and each item is rated on a 5-point scale ranging from "not at all" to "very much," "never" to "always," or "very poor" to "very good." For both PROMIS SRI and PROMIS SD, item responses are used to generate T-scores which are standardized scores with a mean of 50 and a standard deviation of 10 (score range cannot be specified for T-scores). Higher T-scores indicate worse outcomes; more sleep-related impairment (PROMIS SRI) or more sleep disturbance (PROMIS SD).', 'unitOfMeasure': 'T score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide MTD_GPI1', 'description': 'Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo_GPI1', 'description': 'Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.'}, {'id': 'OG002', 'title': 'Tirzepatide MTD_GPI2', 'description': 'Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG003', 'title': 'Placebo_GPI2', 'description': 'Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.65', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '-1.56', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '-19.62', 'spread': '0.71', 'groupId': 'OG002'}, {'value': '-2.34', 'spread': '0.74', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.09', 'ciLowerLimit': '-17.99', 'ciUpperLimit': '-14.19', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.'}, {'pValue': '<.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.28', 'ciLowerLimit': '-19.29', 'ciUpperLimit': '-15.28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Percent Change from Baseline in Body Weight was evaluated.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High Sensitivity C Reactive Protein (hsCRP) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide MTD_GPI1', 'description': 'Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo_GPI1', 'description': 'Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.'}, {'id': 'OG002', 'title': 'Tirzepatide MTD_GPI2', 'description': 'Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG003', 'title': 'Placebo_GPI2', 'description': 'Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.42', 'spread': '0.151', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '0.203', 'groupId': 'OG001'}, {'value': '-1.37', 'spread': '0.130', 'groupId': 'OG002'}, {'value': '-0.33', 'spread': '0.236', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.752', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-1.21', 'ciUpperLimit': '-0.22', 'pValueComment': 'ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.253', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.350', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.04', 'ciLowerLimit': '-1.57', 'ciUpperLimit': '-0.51', 'pValueComment': 'ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.269', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'HsCRP is a marker for inflammation and was measured from blood samples to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.', 'unitOfMeasure': 'Milligram per liter (mg/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirzepatide MTD_GPI1', 'description': 'Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo_GPI1', 'description': 'Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.'}, {'id': 'OG002', 'title': 'Tirzepatide MTD_GPI2', 'description': 'Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'OG003', 'title': 'Placebo_GPI2', 'description': 'Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.46', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '-1.84', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '-7.64', 'spread': '1.03', 'groupId': 'OG002'}, {'value': '-3.94', 'spread': '1.18', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.62', 'ciLowerLimit': '-10.48', 'ciUpperLimit': '-4.77', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.'}, {'pValue': '0.017', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.70', 'ciLowerLimit': '-6.75', 'ciUpperLimit': '-0.65', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'Change in systolic blood pressure from baseline to Week 48 was evaluated.', 'unitOfMeasure': 'Millimeters of mercury (mm Hg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tirzepatide MTD_GPI1', 'description': 'Participants not on positive airway pressure (PAP) therapy received a maximum tolerated dose (MTD) of 10 milligrams (mg) or 15 mg of Tirzepatide once weekly (QW) as a subcutaneous (SC) injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'FG001', 'title': 'Placebo_GPI1', 'description': 'Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.'}, {'id': 'FG002', 'title': 'Tirzepatide MTD_GPI2', 'description': 'Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'FG003', 'title': 'Placebo_GPI2', 'description': 'Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '120'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '115'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '120'}, {'groupId': 'FG002', 'numSubjects': '119'}, {'groupId': 'FG003', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '113'}, {'groupId': 'FG003', 'numSubjects': '89'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Assigned Treatment by Mistake', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Patient could not travel to site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'The participant quit treatment and study due to their schedule and the final V801 was done remotely', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'NCT05412004 supports two pivotal studies: I8F-MC-GPI1 (GPI1; Study 1) and I8F-MC-GPI2 (GPI2; Study 2), conducted under the single master protocol I8F-MC-GPIF. The studies were conducted under a single overarching trial structure for operational efficiencies, but the study participants for both studies are different (GPI1 included participants who were unable or unwilling to use positive airway pressure (PAP) therapy, while GPI2 included those on PAP therapy).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '469', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Tirzepatide MTD_GPI1', 'description': 'Participants not on positive airway pressure (PAP) therapy received a maximum tolerated dose (MTD) of 10 milligrams (mg) or 15 mg of Tirzepatide once weekly (QW) as a subcutaneous (SC) injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'BG001', 'title': 'Placebo_GPI1', 'description': 'Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.'}, {'id': 'BG002', 'title': 'Tirzepatide MTD_GPI2', 'description': 'Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.'}, {'id': 'BG003', 'title': 'Placebo_GPI2', 'description': 'Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<50years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '469', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '224', 'groupId': 'BG004'}]}]}, {'title': '>=50years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '469', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '245', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '469', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '142', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}, {'value': '327', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '469', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '290', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '469', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}, {'value': '325', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '469', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '149', 'groupId': 'BG004'}]}]}, {'title': 'China', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '469', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}]}, {'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '469', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}, {'title': 'Taiwan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '469', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}, {'title': 'Brazil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '469', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}]}, {'title': 'Mexico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '469', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '469', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '469', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}]}, {'title': 'Czechia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '469', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Baseline apnea-hypopnea index (AHI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}, {'value': '466', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '52.86', 'spread': '30.50', 'groupId': 'BG000'}, {'value': '50.13', 'spread': '31.47', 'groupId': 'BG001'}, {'value': '46.08', 'spread': '22.35', 'groupId': 'BG002'}, {'value': '53.10', 'spread': '30.23', 'groupId': 'BG003'}, {'value': '50.49', 'spread': '28.98', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'AHI is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO₂) by at least 4%. AHI values are categorized as 5-15 episodes/hr = mild; 15-\\<30 episodes/hr = moderate; and ≥ 30 episodes/h = severe. a significant reduction in values indicates a positive outcome.', 'unitOfMeasure': 'events per hour', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All randomized participants. Number analysed includes subjects with non-missing data.'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-02', 'size': 1507294, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-13T23:23', 'hasProtocol': True}, {'date': '2024-02-28', 'size': 982424, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-13T23:23', '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': 469}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-12', 'studyFirstSubmitDate': '2022-05-25', 'resultsFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2022-06-08', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-12', 'studyFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Apnea-Hypopnea Index (AHI)', 'timeFrame': 'Baseline, Week 52', 'description': 'AHI, Apnea-Hypopnea Index, is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO₂) by at least 4%. AHI values are categorized as 5-15 events/hr = mild; 15-\\<30 events/hr = moderate; and ≥ 30 events/hr = severe. a significant reduction in values indicates a positive outcome.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Apnea-Hypopnea Index (AHI)', 'timeFrame': 'Baseline, Week 52', 'description': 'Percent Change From Baseline in AHI was evaluated.'}, {'measure': 'Percentage of Participants With ≥50% AHI Reduction From Baseline', 'timeFrame': 'Week 52', 'description': 'Percentage of participants achieving ≥50% AHI reduction from baseline to Week 52 was evaluated.'}, {'measure': 'Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10', 'timeFrame': 'Week 52', 'description': 'The percentage of participants with OSA remission (AHI \\<5 events per hour of sleep) or with mild OSA without excessive daytime sleepiness (AHI 5-14 events per hour of sleep with ESS ≤10) at Week 52 was evaluated. The ESS is used to assess improvements in excessive daytime sleepiness from baseline to Week 52. The ESS is an 8-item, participant-completed measure that asks the participant to rate, on a scale of 0 (no chance of dozing) to 3 (high chance of dozing), their usual chances of dozing in 8 different daytime situations, with a recall period of "in recent times." The ESS total score is the sum of the 8-item scores and ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.'}, {'measure': 'Change From Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% Min/Hour)', 'timeFrame': 'Baseline, Week 52', 'description': 'SASHB was determined by measuring the respiratory event-associated area under the curve for oxygen desaturation from pre-event baseline and represents the cumulative burden of intermittent hypoxia caused by OSA-related sleep-disordered breathing at sleep.'}, {'measure': 'Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a (PROMIS SRI) and PROMIS Short Form Sleep Disturbance 8b (PROMIS SD)', 'timeFrame': 'Baseline, Week 52', 'description': 'PROMIS SRI consists of 8 items that assess self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and perceived functional impairments associated with sleep problems. PROMIS SRI has a recall period of "in the past 7 days" and each item is rated on a 5-point scale from "not at all" to "very much." PROMIS SD consists of 8 items that assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. PROMIS SD has a recall period of "in the past 7 days" and each item is rated on a 5-point scale ranging from "not at all" to "very much," "never" to "always," or "very poor" to "very good." For both PROMIS SRI and PROMIS SD, item responses are used to generate T-scores which are standardized scores with a mean of 50 and a standard deviation of 10 (score range cannot be specified for T-scores). Higher T-scores indicate worse outcomes; more sleep-related impairment (PROMIS SRI) or more sleep disturbance (PROMIS SD).'}, {'measure': 'Percent Change From Baseline in Body Weight', 'timeFrame': 'Baseline, Week 52', 'description': 'Percent Change from Baseline in Body Weight was evaluated.'}, {'measure': 'Change From Baseline in High Sensitivity C Reactive Protein (hsCRP) Concentration', 'timeFrame': 'Baseline, Week 52', 'description': 'HsCRP is a marker for inflammation and was measured from blood samples to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.'}, {'measure': 'Change From Baseline in Systolic Blood Pressure (SBP)', 'timeFrame': 'Baseline, Week 48', 'description': 'Change in systolic blood pressure from baseline to Week 48 was evaluated.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '41135142', 'type': 'DERIVED', 'citation': 'Malhotra A, Grunstein RR, Azarbarzin A, Sands SA, Dang X, Chakladar S, Dunn JP, Falcon B, Bednarik J. Tirzepatide for sleep-disordered breathing in SURMOUNT-OSA: Time course and association with body weight. Sleep Med. 2025 Dec;136:106853. doi: 10.1016/j.sleep.2025.106853. Epub 2025 Oct 14.'}, {'pmid': '40774158', 'type': 'DERIVED', 'citation': 'Kanu C, Shinde S, Chakladar S, Dennehy EB, Weaver TE, Poon JL, Malhotra A. Effect of tirzepatide treatment on patient-reported outcomes among SURMOUNT-OSA participants with obstructive sleep apnea and obesity. Sleep Med. 2025 Oct;134:106719. doi: 10.1016/j.sleep.2025.106719. Epub 2025 Aug 6.'}, {'pmid': '38912654', 'type': 'DERIVED', 'citation': 'Malhotra A, Grunstein RR, Fietze I, Weaver TE, Redline S, Azarbarzin A, Sands SA, Schwab RJ, Dunn JP, Chakladar S, Bunck MC, Bednarik J; SURMOUNT-OSA Investigators. Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity. N Engl J Med. 2024 Oct 3;391(13):1193-1205. doi: 10.1056/NEJMoa2404881. Epub 2024 Jun 21.'}, {'pmid': '38547961', 'type': 'DERIVED', 'citation': 'Malhotra A, Bednarik J, Chakladar S, Dunn JP, Weaver T, Grunstein R, Fietze I, Redline S, Azarbarzin A, Sands SA, Schwab RJ, Bunck MC. Tirzepatide for the treatment of obstructive sleep apnea: Rationale, design, and sample baseline characteristics of the SURMOUNT -OSA phase 3 trial. Contemp Clin Trials. 2024 Jun;141:107516. doi: 10.1016/j.cct.2024.107516. Epub 2024 Mar 26.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.gov/study/NCT05412004?tab=results', 'label': 'Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea (SURMOUNT-OSA)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with moderate to severe obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI1 and those who are and plan to stay on PAP therapy in GPI2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor GPI1 Participants:\n\n\\- Participants who are unable or unwilling to use PAP therapy. Participants must not have used PAP for at least 4 weeks prior to screening.\n\nFor GPI2 Participants:\n\n\\- Have been on PAP therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study\n\nFor Both GPI1 and GPI2 Participants:\n\n* Have an AHI ≥15 on PSG as part of the trial at screening\n* Have a body mass index (BMI) ≥30 kilogram/square meter (kg/m²)\n* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight\n\nExclusion Criteria:\n\nFor GPI2 Participants:\n\n* Have personal or job-related responsibilities, or in the opinion of the investigator have any situation, that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the course of the study\n* Are unwilling to stop PAP therapy for 7 days prior to polysomnography (PSG) testing during the course of the study\n\nFor GPI1 and GPI2 Participants:\n\n* Female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed.\n* Have type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma.\n* Have HbA1c ≥ 6.5% (≥ 48 mmol/mol) at baseline\n* Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of baseline\n* Have significant craniofacial abnormalities that may affect breathing at baseline\n* Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration\n* Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.\n* Active device treatment of OSA other than PAP therapy (for example, dental appliance), or other treatment, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at baseline and throughout the study.\n* Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.\n* Have a self-reported change in body weight \\>5 kg within 3 months prior to screening\n* Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed more than 1 year prior to screening)\n* Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months (for example, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal bypass sleeve)'}, 'identificationModule': {'nctId': 'NCT05412004', 'acronym': 'SURMOUNT-OSA', 'briefTitle': 'Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Master Protocol to Investigate the Efficacy and Safety of Tirzepatide Once Weekly in Participants Who Have Obstructive Sleep Apnea and Obesity: A Randomized, Double-Blind, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': '18357'}, 'secondaryIdInfos': [{'id': 'I8F-MC-GPIF', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'I8F-MC-GPI1', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'I8F-MC-GPI2', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2021-004552-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tirzepatide MTD_GPI1', 'description': 'Participants not on positive airway pressure (PAP) therapy received a maximum tolerated dose (MTD) of 10 milligrams (mg) or 15 mg of Tirzepatide once weekly (QW) as a subcutaneous (SC) injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks', 'interventionNames': ['Drug: Tirzepatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo_GPI1', 'description': 'Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Tirzepatide MTD_GPI2', 'description': 'Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks', 'interventionNames': ['Drug: Tirzepatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo_GPI2', 'description': 'Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tirzepatide', 'type': 'DRUG', 'otherNames': ['LY3298176'], 'description': 'Administered SC', 'armGroupLabels': ['Tirzepatide MTD_GPI1', 'Tirzepatide MTD_GPI2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo_GPI1', 'Placebo_GPI2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92503', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Teradan Clinical Trials, LLC', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '34470', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Renstar Medical Research', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Beach Research Center', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'NeuroTrials Research Inc', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Rocky Mountain Clinical Research', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Brengle Family Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Lillestol Research', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'NeuroScience Research Center', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'CTI-CRC', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '15236', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Office 18', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15401', 'city': 'Uniontown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Preferred Primary Care Physicians', 'geoPoint': {'lat': 39.90008, 'lon': -79.71643}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'FutureSearch Trials of Neurology', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77702', 'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'facility': 'Gadolin Research', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'zip': '79912', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Advanced Neuro Research Center - ANRC', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '75154', 'city': 'Red Oak', 'state': 'Texas', 'country': 'United States', 'facility': 'Epic Medical Research', 'geoPoint': {'lat': 32.51764, 'lon': -96.80444}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Sleep Therapy Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Rainier Clinical Research Center', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': '2037', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Woolcock Institute of Medical Research', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '5042', 'city': 'Bedford Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Flinders University', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'zip': '90430-001', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Núcleo de Pesquisa Clínica do Rio Grande do Sul', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '01228-200', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'CPCLIN', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '01228-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'CPQuali Pesquisa Clínica', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04266-010', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clinicas FMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05003-090', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'BR Trials - Ensaios Clinicos e Consultoria', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05403-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clinicas FMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'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': '214023', 'city': 'Wuxi', 'state': 'Jiangsu', 'country': 'China', 'facility': "Wuxi People's Hospital", 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital,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': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '12808', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Vseobecna fakultni nemocnice v Praze', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '150 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Praglandia s.r.o', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '30449', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Siteworks GmbH', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '45136', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'InnoDiab Forschung Gmbh', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '48145', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Institut für Diabetesforschung GmbH Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '23758', 'city': 'Oldenburg in Holstein', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'RED-Institut GmbH', 'geoPoint': {'lat': 54.29498, 'lon': 10.89043}}, {'zip': '24837', 'city': 'Schleswig', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Lungenpraxis Schleswig', 'geoPoint': {'lat': 54.52021, 'lon': 9.56829}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Advanced Sleep Research', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '22607', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Diabeteszentrum Hamburg West', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '457-8511', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Koujunkai Daido Clinic', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '802-0052', 'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kirigaokatsuda Hospital', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'zip': '222-0033', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'RESM Respiratory and Sleep Medical Care Clinic', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '593-8304', 'city': 'Sakai', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Sakai City Medical Center', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}, {'zip': '104-0031', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Fukuwa Clinic'}, {'zip': '532-0003', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Kaisei Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '44670', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Private Practice - Dr. Arechavaleta Granell Maria del Rosario', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44670', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Unidad de Investigación Clínica y Atención Médica HEPA', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '03100', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'RM Pharma Specialists', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '11650', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '66450', 'city': 'San Nicolás de los Garza', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Servicios Integrales Nova de Monterrey S.A. de C.V.', 'geoPoint': {'lat': 25.74167, 'lon': -100.30222}}, {'zip': '66465', 'city': 'San Nicolás de los Garza', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Unidad Médica para la Salud Integral', 'geoPoint': {'lat': 25.74167, 'lon': -100.30222}}, {'zip': '31217', 'city': 'Chihuahua City', 'country': 'Mexico', 'facility': 'Investigacion En Salud Y Metabolismo Sc', 'geoPoint': {'lat': 28.63528, 'lon': -106.08889}}, {'zip': '91910', 'city': 'Veracruz', 'country': 'Mexico', 'facility': 'Arké SMO S.A de C.V', 'geoPoint': {'lat': 19.18095, 'lon': -96.1429}}, {'zip': '00917', 'city': 'Hato Rey', 'state': 'Puerto Rico', 'country': 'Puerto Rico', 'facility': 'Puerto Rico Medical Research Center'}, {'zip': '404332', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '704', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': '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 Union (EU), whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}