Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-03-26 @ 8:33 PM
Study NCT ID:
NCT01147250
Status:
COMPLETED
Last Update Posted:
2016-12-20
First Post:
2010-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479460', 'term': 'lixisenatide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'title': 'Trail Transparency Team', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame.', 'description': "Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.", 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants exposed to Placebo matched to lixisenatide QD. (Median exposure: 23 months)', 'otherNumAtRisk': 3032, 'otherNumAffected': 1270, 'seriousNumAtRisk': 3032, 'seriousNumAffected': 669}, {'id': 'EG001', 'title': 'Lixisenatide', 'description': 'Participants exposed to Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to 225 weeks. (Median exposure: 22 months)', 'otherNumAtRisk': 3031, 'otherNumAffected': 1597, 'seriousNumAtRisk': 3031, 'seriousNumAffected': 625}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 188}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 181}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 554}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 609}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 191}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 259}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 148}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 187}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 200}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 177}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 171}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 152}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 179}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 659}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 257}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 227}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 237}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 171}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 137}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diabetic foot infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Infected skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Infective exacerbation of chronic obstructive airways disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pyelonephritis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Arthritis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bone abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bronchitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Colonic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gallbladder abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastroenteritis clostridial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Groin abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'H1N1 influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Helicobacter gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Infected bites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Mediastinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Mycobacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nail bed infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Osteomyelitis fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Paraspinal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Puncture site abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Renal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Scrotal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Toxoplasmosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal wall infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Amoebic dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bacterial pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bronchitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Chronic hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 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0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Osteomyelitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Osteomyelitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Otitis media chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pleurisy viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Psoas abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pulmonary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Staphylococcal osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Subdiaphragmatic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Tick-borne fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Viral corneal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 10}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Adenocarcinoma gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Benign neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Benign renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Benign salivary gland neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Benign small intestinal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Colon cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Colon cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastric cancer stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Glioblastoma multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Iris melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Keratoacanthoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lip squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Metastases to pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Metastatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ovarian cancer stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ovarian epithelial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Phaeochromocytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pharyngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pituitary tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Prostate cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Prostatic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Renal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Retroperitoneal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Adenocarcinoma pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Adenosquamous cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'B-cell unclassifiable lymphoma low grade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Clear cell renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 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'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gallbladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rectal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Salivary gland neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Skin cancer', 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3031, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 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'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Leg amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pleurodesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Toe amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Implantable defibrillator insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Intraocular lens implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Peripheral artery bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Joint prosthesis user', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3032, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3031, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3034', 'groupId': 'OG000'}, {'value': '3034', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).'}, {'id': 'OG001', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '399', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.017', 'ciLowerLimit': '0.886', 'ciUpperLimit': '1.168', 'estimateComment': 'Lixisenatide vs Placebo', 'groupDescription': 'Analysis was performed using Cox proportional hazards model with treatment groups, and region (North America, South and Central America, Western Europe, Eastern Europe, Africa/Near East, and Asia/Pacific) as covariates, and the associated two-sided 95% confidence interval (CI).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority of lixisenatide versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio was \\<1.3.'}, {'pValue': '0.8542', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.017', 'ciLowerLimit': '0.886', 'ciUpperLimit': '1.168', 'estimateComment': 'Lixisenatide vs Placebo', 'groupDescription': 'Analysis was performed using Cox proportional hazards model with treatment groups, and region (North America, South and Central America, Western Europe, Eastern Europe, Africa/Near East, and Asia/Pacific) as covariates, and the associated two-sided 95% CI. Superiority of lixisenatide versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio was \\<1.0.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization up to the end of study (median follow-up of 25 months)', 'description': 'Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the onset of primary CV endpoint over time. Number of observed participants with endpoint events were reported. A CV event adjudication committee (CAC) reviewed and adjudicated, in a blinded fashion, all potential events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population defined as all randomized participants analyzed according to the treatment group allocated at randomization.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3034', 'groupId': 'OG000'}, {'value': '3034', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).'}, {'id': 'OG001', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '469', 'groupId': 'OG000'}, {'value': '456', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization up to the end of study (median follow-up of 25 months)', 'description': 'All CV events were positively adjudicated by the CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure. Number of observed participants with endpoint events were reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3034', 'groupId': 'OG000'}, {'value': '3034', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).'}, {'id': 'OG001', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '659', 'groupId': 'OG000'}, {'value': '661', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization up to the end of study (median follow-up of 25 months)', 'description': 'All CV events were positively adjudicated by CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. Number of observed participants with endpoint events were reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2830', 'groupId': 'OG000'}, {'value': '2803', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).'}, {'id': 'OG001', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '34.21', 'spread': '3.09', 'groupId': 'OG000'}, {'value': '24.17', 'spread': '2.84', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline to Week 108 (LOCF)', 'description': 'Presence of albumin in urine is a marker of nephropathy, an important microvascular complication of diabetes. UACR was defined as the ratio: mg of albumin per gram of creatinine. UACR data were log transformed before the analysis. Calculation was based on geometric mean.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline UACR value. Missing data was imputed using last observation carried forward (LOCF) using the last available post-baseline UACR before Week 108 as the value at Week 108, regardless of treatment discontinuation or not.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo matched to lixisenatide once daily (QD) subcutaneously (SC) up to end of treatment (median exposure: 23 months).'}, {'id': 'FG001', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3034'}, {'groupId': 'FG001', 'numSubjects': '3034'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3032'}, {'groupId': 'FG001', 'numSubjects': '3031'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2924'}, {'groupId': 'FG001', 'numSubjects': '2929'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '105'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'Site termination by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 829 centers in 49 countries. A total of 7719 participants were screened between June 24, 2010 and July 24, 2013. 1651 of whom were screen failures. Screen failures were mainly due to exclusion criteria met.', 'preAssignmentDetails': '7627 participants underwent 1 week placebo run-in period. 1559 were run-in failures due to exclusion criteria met. 6068 participants were randomized 1:1 to lixisenatide and placebo arms in double-blind treatment period. Duration of study was event driven until approximately 844 positively adjudicated primary cardiovascular (CV) outcome events.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3034', 'groupId': 'BG000'}, {'value': '3034', 'groupId': 'BG001'}, {'value': '6068', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).'}, {'id': 'BG001', 'title': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.6', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '59.9', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '60.3', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '938', 'groupId': 'BG000'}, {'value': '923', 'groupId': 'BG001'}, {'value': '1861', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2096', 'groupId': 'BG000'}, {'value': '2111', 'groupId': 'BG001'}, {'value': '4207', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race', 'classes': [{'title': 'Caucasian/White', 'categories': [{'measurements': [{'value': '2318', 'groupId': 'BG000'}, {'value': '2258', 'groupId': 'BG001'}, {'value': '4576', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}]}, {'title': 'Asian/Oriental', 'categories': [{'measurements': [{'value': '367', 'groupId': 'BG000'}, {'value': '404', 'groupId': 'BG001'}, {'value': '771', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '246', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ethnicity', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '903', 'groupId': 'BG000'}, {'value': '865', 'groupId': 'BG001'}, {'value': '1768', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic', 'categories': [{'measurements': [{'value': '2131', 'groupId': 'BG000'}, {'value': '2169', 'groupId': 'BG001'}, {'value': '4300', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Qualifying Acute Coronary Syndrome (ACS) event', 'classes': [{'title': 'ST-segment elevation myocardial infarction (MI)', 'categories': [{'measurements': [{'value': '1317', 'groupId': 'BG000'}, {'value': '1349', 'groupId': 'BG001'}, {'value': '2666', 'groupId': 'BG002'}]}]}, {'title': 'Non ST-segment elevation MI', 'categories': [{'measurements': [{'value': '1183', 'groupId': 'BG000'}, {'value': '1165', 'groupId': 'BG001'}, {'value': '2348', 'groupId': 'BG002'}]}]}, {'title': 'Unstable angina', 'categories': [{'measurements': [{'value': '528', 'groupId': 'BG000'}, {'value': '514', 'groupId': 'BG001'}, {'value': '1042', 'groupId': 'BG002'}]}]}, {'title': 'Unclassified', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Not qualifying ACS event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '30.2', 'spread': '5.79', 'groupId': 'BG000'}, {'value': '30.12', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '30.16', 'spread': '5.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'N=3032, 3033', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '85.06', 'spread': '19.64', 'groupId': 'BG000'}, {'value': '84.64', 'spread': '19.21', 'groupId': 'BG001'}, {'value': '84.85', 'spread': '19.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'N=3032, 3033', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycosylated Hemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '7.64', 'spread': '1.28', 'groupId': 'BG000'}, {'value': '7.72', 'spread': '1.32', 'groupId': 'BG001'}, {'value': '7.68', 'spread': '1.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'N=3033, 3034', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '9.38', 'spread': '8.32', 'groupId': 'BG000'}, {'value': '9.2', 'spread': '8.19', 'groupId': 'BG001'}, {'value': '9.29', 'spread': '8.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'N=3034, 3031', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6068}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'dispFirstSubmitDate': '2016-02-16', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-31', 'studyFirstSubmitDate': '2010-06-17', 'dispFirstSubmitQcDate': '2016-02-16', 'resultsFirstSubmitDate': '2016-08-22', 'studyFirstSubmitQcDate': '2010-06-17', 'dispFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-12-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-22', 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina', 'timeFrame': 'From randomization up to the end of study (median follow-up of 25 months)', 'description': 'Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the onset of primary CV endpoint over time. Number of observed participants with endpoint events were reported. A CV event adjudication committee (CAC) reviewed and adjudicated, in a blinded fashion, all potential events.'}], 'secondaryOutcomes': [{'measure': 'Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure', 'timeFrame': 'From randomization up to the end of study (median follow-up of 25 months)', 'description': 'All CV events were positively adjudicated by the CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure. Number of observed participants with endpoint events were reported.'}, {'measure': 'Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure', 'timeFrame': 'From randomization up to the end of study (median follow-up of 25 months)', 'description': 'All CV events were positively adjudicated by CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. Number of observed participants with endpoint events were reported.'}, {'measure': 'Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108', 'timeFrame': 'Baseline to Week 108 (LOCF)', 'description': 'Presence of albumin in urine is a marker of nephropathy, an important microvascular complication of diabetes. UACR was defined as the ratio: mg of albumin per gram of creatinine. UACR data were log transformed before the analysis. Calculation was based on geometric mean.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '25965710', 'type': 'BACKGROUND', 'citation': 'Bentley-Lewis R, Aguilar D, Riddle MC, Claggett B, Diaz R, Dickstein K, Gerstein HC, Johnston P, Kober LV, Lawson F, Lewis EF, Maggioni AP, McMurray JJ, Ping L, Probstfield JL, Solomon SD, Tardif JC, Wu Y, Pfeffer MA; ELIXA Investigators. Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo. Am Heart J. 2015 May;169(5):631-638.e7. doi: 10.1016/j.ahj.2015.02.002. Epub 2015 Feb 12.'}, {'pmid': '26630143', 'type': 'RESULT', 'citation': 'Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Kober LV, Lawson FC, Ping L, Wei X, Lewis EF, Maggioni AP, McMurray JJ, Probstfield JL, Riddle MC, Solomon SD, Tardif JC; ELIXA Investigators. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med. 2015 Dec 3;373(23):2247-57. doi: 10.1056/NEJMoa1509225.'}, {'pmid': '39963952', 'type': 'DERIVED', 'citation': 'Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.'}, {'pmid': '36546588', 'type': 'DERIVED', 'citation': 'Gerstein HC, Wolsk E, Claggett B, Diaz R, Dickstein K, Hess S, Kober L, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Pfeffer MA. 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Retinopathy, Neuropathy, and Subsequent Cardiovascular Events in Patients with Type 2 Diabetes and Acute Coronary Syndrome in the ELIXA: The Importance of Disease Duration. J Diabetes Res. 2018 Dec 16;2018:1631263. doi: 10.1155/2018/1631263. eCollection 2018.'}, {'pmid': '30292589', 'type': 'DERIVED', 'citation': 'Muskiet MHA, Tonneijck L, Huang Y, Liu M, Saremi A, Heerspink HJL, van Raalte DH. Lixisenatide and renal outcomes in patients with type 2 diabetes and acute coronary syndrome: an exploratory analysis of the ELIXA randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018 Nov;6(11):859-869. doi: 10.1016/S2213-8587(18)30268-7. Epub 2018 Oct 3.'}, {'pmid': '29693361', 'type': 'DERIVED', 'citation': 'Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.'}, {'pmid': '28554908', 'type': 'DERIVED', 'citation': 'Wolsk E, Claggett B, Pfeffer MA, Diaz R, Dickstein K, Gerstein HC, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Kober L. Role of B-Type Natriuretic Peptide and N-Terminal Prohormone BNP as Predictors of Cardiovascular Morbidity and Mortality in Patients With a Recent Coronary Event and Type 2 Diabetes Mellitus. J Am Heart Assoc. 2017 May 29;6(6):e004743. doi: 10.1161/JAHA.116.004743.'}, {'pmid': '23537041', 'type': 'DERIVED', 'citation': 'Wohlfart P, Linz W, Hubschle T, Linz D, Huber J, Hess S, Crowther D, Werner U, Ruetten H. Cardioprotective effects of lixisenatide in rat myocardial ischemia-reperfusion injury studies. J Transl Med. 2013 Mar 28;11:84. doi: 10.1186/1479-5876-11-84.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n\\- To demonstrate that lixisenatide can reduce cardiovascular (CV) morbidity and mortality (composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina) compared to placebo in type 2 diabetic participants who recently experienced an acute coronary syndrome (ACS) event.\n\nSecondary Objectives:\n\nTo demonstrate that when compared to placebo, lixisenatide can reduce:\n\n* composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure.\n* composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure.\n* urinary albumin excretion (based on the urinary albumin/creatinine ratio).\n\nTo assess the safety and tolerability of lixisenatide.', 'detailedDescription': 'The estimated maximum study duration for the first randomized participant was approximately 204 weeks (± 14 days), with a median follow-up over all participants of approximately 91 weeks, broken down as follows:\n\n* placebo-run-in period: 7 days (+ 3 days)\n* double-blind study treatment period: 203 weeks (± 14 days) (with about a 37 months of recruitment period)\n* post-treatment follow-up period: 3 days (± 1 day)\n\nAll participants were followed from randomization until the end of study, which should occur when the last randomized participant had been followed for approximately 10 months. The actual end date of the study was "event driven" and the study end when there were approximately 844 positively-adjudicated primary cardiovascular outcome events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Men and women who experienced a spontaneous ACS event (i.e., ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation MI (NSTEMI) or unstable angina) with a documented elevation above the normal reference range of a cardiac biomarker (Troponin or Creatinine Kinase (CK)-MB) and the clinical presentation consistent with an ACS which lead to admission to an acute care facility, within 180 days following the ACS event and prior to screening.\n* Participants with a history of type 2 diabetes (for participants newly diagnosed, diagnosis was based on the World Health Organization (WHO) criteria: i.e., either a fasting venous plasma glucose concentration ≥ 7.0 mmol/L \\[126 mg/dL\\] or 2-hour post glucose load venous plasma glucose ≥ 11.1 mmol/L \\[200 mg/dL\\], confirmed on 2 occasions) prior to the screening visit.\n\nExclusion criteria:\n\n* Type 1 diabetes mellitus or history of ketoacidosis within 6 months prior to screening.\n* Glycosylated hemoglobin (HbA1c) \\<5.5 % or \\>11% measured at screening visit.\n* Required to use incretin-based agents (e.g., Glucagon-like peptide -1 (GLP-1) agonists or Dipeptidyl Peptidase-4 (DPP-4) inhibitors) other than the study drug during the double-blind treatment period.\n* Participants who had undergone coronary artery bypass graft (CABG) surgery following the qualifying ACS event.\n* Participants who had undergone percutaneous coronary intervention (PCI) within 15 days prior to screening.\n* Participants with planned revascularization procedure (PCI or CABG) or coronary angiogram within 90 days after screening visit.\n* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC), or genetic conditions that predisposes to MTC (e.g., multiple endocrine neoplasia syndromes).\n* Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01147250', 'acronym': 'ELIXA', 'briefTitle': 'Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'EFC11319'}, 'secondaryIdInfos': [{'id': '2009-012852-26', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1116-5558', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo matched to lixisenatide once daily (QD) up to end of treatment.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Lixisenatide', 'description': 'Lixisenatide 10 mcg QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment.', 'interventionNames': ['Drug: Lixisenatide (AVE0010)']}], 'interventions': [{'name': 'Lixisenatide (AVE0010)', 'type': 'DRUG', 'otherNames': ['Lyxumia'], 'description': 'Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast using self-injector pen device (Opticlik®). If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 15 or 10 mcg.', 'armGroupLabels': ['Lixisenatide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35203', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 840415', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36535', 'city': 'Foley', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 840307', 'geoPoint': {'lat': 30.40659, 'lon': -87.6836}}, {'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 840692', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 840037', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36609', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 840210', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '35661', 'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 840326', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'zip': '35773', 'city': 'Toney', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 840393', 'geoPoint': {'lat': 34.89814, 'lon': -86.73361}}, {'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840656', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840506', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840520', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840322', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85284', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840250', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840042', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigational Site Number 840303', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigational Site Number 840184', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72204', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigational Site Number 840361', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigational Site Number 840023', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840706', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840497', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840667', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '93722', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840150', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90250', 'city': 'Hawthorne', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840624', 'geoPoint': {'lat': 33.9164, 'lon': -118.35257}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840623', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840636', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840455', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840240', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840262', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840606', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840694', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840431', 'geoPoint': {'lat': 34.05223, 'lon': 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'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840654', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840351', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840689', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '91767', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840582', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '93041', 'city': 'Port Hueneme', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840346', 'geoPoint': {'lat': 34.14778, 'lon': -119.19511}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840466', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '91108', 'city': 'San Marino', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840575', 'geoPoint': {'lat': 34.1214, 'lon': -118.10646}}, {'zip': '82705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840131', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '92704', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840335', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '93065', 'city': 'Simi Valley', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840576', 'geoPoint': {'lat': 34.26945, 'lon': -118.78148}}, {'zip': '91342', 'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840414', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840395', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '92081-7832', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840206', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '91361', 'city': 'Westlake Village', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840480', 'geoPoint': {'lat': 34.14584, 'lon': -118.80565}}, {'zip': '90602', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840350', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '80910', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 840093', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '20060', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Investigational Site Number 840631', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20422', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Investigational Site Number 840044', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33755', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840281', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '34448', 'city': 'Homosassa', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840477', 'geoPoint': {'lat': 28.78137, 'lon': -82.6151}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840261', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840459', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32765', 'city': 'Oviedo', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840432', 'geoPoint': {'lat': 28.67, 'lon': -81.20812}}, {'zip': '32401', 'city': 'Panama City', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840318', 'geoPoint': {'lat': 30.15946, 'lon': -85.65983}}, {'zip': '33707', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840056', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33449', 'city': 'Wellington', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840295', 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840066', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840446', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840487', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30513', 'city': 'Blue Ridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840578', 'geoPoint': {'lat': 34.86397, 'lon': -84.32409}}, {'zip': '31904-5245', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840534', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '30096', 'city': 'Duluth', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840447', 'geoPoint': {'lat': 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'Investigational Site Number 376002', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '35251', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Investigational Site Number 376008', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '58100', 'city': 'Holon', 'country': 'Israel', 'facility': 'Investigational Site Number 376001', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}, {'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Investigational Site Number 376012', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '22100', 'city': 'Nahariya', 'country': 'Israel', 'facility': 'Investigational Site Number 376011', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}, {'zip': '13100', 'city': 'Safed', 'country': 'Israel', 'facility': 'Investigational Site Number 376005', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Investigational Site Number 376004', 'geoPoint': {'lat': 32.08088, 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40.87618, 'lon': 14.5195}}, {'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'facility': 'Investigational Site Number 380019', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'zip': '90127', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Investigational Site Number 380005', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '56124', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Investigational Site Number 380001', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '00128', 'city': 'Roma', 'country': 'Italy', 'facility': 'Investigational Site Number 380013', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '20089', 'city': 'Rozzano', 'country': 'Italy', 'facility': 'Investigational Site Number 380020', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'Chūōku', 'country': 'Japan', 'facility': 'Investigational Site Number 392011', 'geoPoint': {'lat': 33.63867, 'lon': 130.67068}}, {'city': 'Fuchu-Shi', 'country': 'Japan', 'facility': 'Investigational 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'Japan', 'facility': 'Investigational Site Number 392007', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Matsuyama', 'country': 'Japan', 'facility': 'Investigational Site Number 392008', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Nagasaki', 'country': 'Japan', 'facility': 'Investigational Site Number 392009', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Noda', 'country': 'Japan', 'facility': 'Investigational Site Number 392002', 'geoPoint': {'lat': 35.94897, 'lon': 139.86793}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Investigational Site Number 392020', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Investigational Site Number 392021', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Investigational Site Number 392001', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Investigational Site Number 392010', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Setagaya-Ku', 'country': 'Japan', 'facility': 'Investigational Site Number 392024'}, {'city': 'Shinagawa-Ku', 'country': 'Japan', 'facility': 'Investigational Site Number 392004'}, {'city': 'Shirakawa-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392014'}, {'city': 'Suita-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392018'}, {'city': 'Tachikawa-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392016'}, {'city': 'Takasaki-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392023'}, {'zip': 'LV-4101', 'city': 'Cēsis', 'country': 'Latvia', 'facility': 'Investigational Site Number 428005', 'geoPoint': {'lat': 57.31188, 'lon': 25.27456}}, {'zip': 'LV-5417', 'city': 'Daugavpils', 'country': 'Latvia', 'facility': 'Investigational Site Number 428001', 'geoPoint': {'lat': 55.88333, 'lon': 26.53333}}, {'zip': 'LV-3414', 'city': 'Liepāja', 'country': 'Latvia', 'facility': 'Investigational Site Number 428002', 'geoPoint': {'lat': 56.50474, 'lon': 21.01085}}, {'zip': 'LV-1002', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Investigational Site Number 428003', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV-1011', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Investigational Site Number 428007', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV-1038', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Investigational Site Number 428004', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV-2150', 'city': 'Sigulda', 'country': 'Latvia', 'facility': 'Investigational Site Number 428006', 'geoPoint': {'lat': 57.15375, 'lon': 24.85953}}, {'zip': 'LT-49456', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Investigational Site Number 440003', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': 'LT-50009', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Investigational Site Number 440002', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': 'LT-91131', 'city': 'Klaipėda', 'country': 'Lithuania', 'facility': 'Investigational Site Number 440004', 'geoPoint': {'lat': 55.7068, 'lon': 21.13912}}, {'zip': 'LT-92304', 'city': 'Klaipėda', 'country': 'Lithuania', 'facility': 'Investigational Site Number 440006', 'geoPoint': {'lat': 55.7068, 'lon': 21.13912}}, {'zip': 'LT-37355', 'city': 'Panevezys', 'country': 'Lithuania', 'facility': 'Investigational Site Number 440005', 'geoPoint': {'lat': 55.73186, 'lon': 24.35983}}, {'zip': 'LT-08661', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Investigational Site Number 440001', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '39670', 'city': 'Acapulco', 'country': 'Mexico', 'facility': 'Investigational Site Number 484011', 'geoPoint': {'lat': 16.11417, 'lon': -91.51028}}, {'zip': '20230', 'city': 'Aguascalientes', 'country': 'Mexico', 'facility': 'Investigational Site Number 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24.02032, 'lon': -104.65756}}, {'zip': '44150', 'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Investigational Site Number 484032', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44160', 'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Investigational Site Number 484034', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44210', 'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Investigational Site Number 484014', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44210', 'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Investigational Site Number 484028', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44670', 'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Investigational Site Number 484021', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44680', 'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Investigational Site Number 484006', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '45200', 'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Investigational Site Number 484018', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '37150', 'city': 'León', 'country': 'Mexico', 'facility': 'Investigational Site Number 484024', 'geoPoint': {'lat': 25.60187, 'lon': -103.47698}}, {'zip': '06470', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Investigational Site Number 484026', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '07300', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Investigational Site Number 484022', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '14000', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Investigational Site Number 484013', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '64020', 'city': 'Monterrey', 'country': 'Mexico', 'facility': 'Investigational Site Number 484003', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '64060', 'city': 'Monterrey', 'country': 'Mexico', 'facility': 'Investigational Site Number 484025', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '64460', 'city': 'Monterrey', 'country': 'Mexico', 'facility': 'Investigational Site Number 484002', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '64460', 'city': 'Monterrey', 'country': 'Mexico', 'facility': 'Investigational Site Number 484005', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '64620', 'city': 'Monterrey', 'country': 'Mexico', 'facility': 'Investigational Site Number 484004', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '58260', 'city': 'Morelia', 'country': 'Mexico', 'facility': 'Investigational Site Number 484035', 'geoPoint': {'lat': 19.70078, 'lon': -101.18443}}, {'zip': '78200', 'city': 'San Luis Potosí City', 'country': 'Mexico', 'facility': 'Investigational Site Number 484020', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}, {'zip': '54055', 'city': 'Tlalnepantla', 'country': 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'Lima', 'country': 'Peru', 'facility': 'Investigational Site Number 604013', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '12', 'city': 'Lima', 'country': 'Peru', 'facility': 'Investigational Site Number 604010', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '27', 'city': 'Lima', 'country': 'Peru', 'facility': 'Investigational Site Number 604002', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '27', 'city': 'Lima', 'country': 'Peru', 'facility': 'Investigational Site Number 604006', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '511', 'city': 'Lima', 'country': 'Peru', 'facility': 'Investigational Site Number 604015', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '511', 'city': 'Lima', 'country': 'Peru', 'facility': 'Investigational Site Number 604016', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'LIMA 01', 'city': 'Lima', 'country': 'Peru', 'facility': 'Investigational Site Number 604017', 'geoPoint': 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