Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-27 @ 5:45 PM
Study NCT ID:
NCT01931566
Status:
TERMINATED
Last Update Posted:
2019-09-16
First Post:
2013-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Biomarker Qualification for Risk of Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease (AD) and Safety and Efficacy Evaluation of Pioglitazone in Delaying Its Onset
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy', 'Russia']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 30 days after the last dose of study drug (up to 935 days)', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Low Risk Placebo', 'description': 'Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to low risk group for developing MCI-AD for up to 5 years.', 'otherNumAtRisk': 427, 'deathsNumAtRisk': 427, 'otherNumAffected': 235, 'seriousNumAtRisk': 427, 'deathsNumAffected': 2, 'seriousNumAffected': 81}, {'id': 'EG001', 'title': 'High Risk Placebo', 'description': 'Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.', 'otherNumAtRisk': 1507, 'deathsNumAtRisk': 1507, 'otherNumAffected': 828, 'seriousNumAtRisk': 1507, 'deathsNumAffected': 21, 'seriousNumAffected': 404}, {'id': 'EG002', 'title': 'High Risk Pioglitazone', 'description': 'Pioglitazone 0.8 mg, sustained release (SR) tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.', 'otherNumAtRisk': 1531, 'deathsNumAtRisk': 1531, 'otherNumAffected': 822, 'seriousNumAtRisk': 1531, 'deathsNumAffected': 7, 'seriousNumAffected': 358}], 'otherEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 119}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 106}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 72}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 190}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 183}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 178}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 191}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 72}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 90}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 52}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 143}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 135}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 125}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 125}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 101}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 81}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 86}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 71}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 79}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 76}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 97}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 93}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Myocardial infarction', 'notes': 'Four treatment-emergent deaths occurred during treatment with placebo (in high-risk group) and were not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Cardiac failure congestive', 'notes': 'One treatment-emergent death occurred during treatment with placebo (in high-risk group) and was related. One treatment-emergent death occurred during treatment with placebo (in high-risk group) and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Acute myocardial infarction', 'notes': 'One treatment-emergent death occurred during treatment with pioglitazone (in high-risk group) and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Cardiac arrest', 'notes': 'Two treatment-emergent deaths occurred during treatment with placebo (in high-risk group) and were not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Myocardial ischaemia', 'notes': 'One treatment-emergent death occurred during treatment with pioglitazone (in high-risk group) and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Arteriospasm coronary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Atrial septal defect acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Mitral valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Tricuspid valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Congenital cerebrovascular anomaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Macular fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Dacryostenosis acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 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{'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Incarcerated inguinal hernia', 'stats': 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{'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Pubis fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Traumatic intracranial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 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'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Avulsion fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Cataract operation complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Extradural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Flatback syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Fracture displacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Fractured ischium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Fractured sacrum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Postoperative ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Postoperative respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Procedural intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Procedural vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Sternal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Stress fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Subdural haemorrhage', 'notes': 'One treatment-emergent death occurred in participant who also suffered from cerebrovascular accident during treatment with placebo (in high-risk group) and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Wound secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Blood magnesium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Blood parathyroid hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Heart rate irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Cerebral salt-wasting syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 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'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': "Dupuytren's contracture", 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Fracture pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Joint instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 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'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Myosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Polymyalgia rheumatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Sacroiliitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Scoliosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Seronegative arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Tendon disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Vertebral foraminal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Vertebral osteophyte', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Pancreatic 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Two treatment-emergent deaths occurred during treatment with placebo (in high-risk group) and were not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Parathyroid tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Squamous cell carcinoma of lung', 'notes': 'One treatment-emergent death occurred during treatment with pioglitazone (in high-risk group) and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Anal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Benign neoplasm of thyroid gland', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Benign renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Bladder cancer stage 0, with cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Breast cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Cardiac myxoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Cholangiocarcinoma', 'notes': 'One treatment-emergent death occurred during treatment with pioglitazone (in high-risk group) and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Choroid plexus papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Colon cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Follicular thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Gastrointestinal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Glioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Intracranial meningioma malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Invasive papillary breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Large intestine benign neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Laryngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Lung adenocarcinoma stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Lung cancer metastatic', 'notes': 'One treatment-emergent death occurred during treatment with placebo (in high-risk group) and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Lung carcinoma cell type unspecified stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Mantle cell lymphoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Metastatic malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Mucinous breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Non-small cell lung cancer stage IIIB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Oesophageal adenocarcinoma', 'notes': 'One treatment-emergent death occurred during treatment with placebo (in high-risk group) and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Oesophageal carcinoma', 'notes': 'One treatment-emergent death occurred during treatment with placebo (in high-risk group) and was related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Oesophageal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Ovarian adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Papillary cystadenoma lymphomatosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Penile squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Pituitary tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Plasmacytoma', 'notes': 'One treatment-emergent death occurred during treatment with pioglitazone (in high-risk group) and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Polycythaemia vera', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Schwannoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Spinal cord neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Squamous cell carcinoma of the tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Tongue neoplasm malignant stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Tonsil cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Cerebrovascular accident', 'notes': 'One treatment-emergent death occurred in participant who also suffered from subdural haemorrhage during treatment with placebo (in high-risk group) and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Cerebral haemorrhage', 'notes': 'One treatment-emergent death occurred during treatment with placebo (in high-risk group) and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Transient global amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 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'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Respiratory failure', 'notes': 'One treatment-emergent death occurred during treatment with pioglitazone (in high-risk group) and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Cough', 'notes': 'One treatment-emergent death occurred during treatment with pioglitazone (in high-risk group) and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Idiopathic pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Pulmonary granuloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Precancerous skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Shoulder arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Hypotension', 'notes': 'One treatment-emergent death occurred during treatment with placebo (in low-risk group) and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Superior mesenteric artery syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 427, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1507, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1531, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Time to Diagnosis of Mild Cognitive Impairment Due to Alzheimer's Disease (MCI-AD) for Placebo-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, Low-risk, Non-Hispanic/Latino Caucasian Participants", 'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'OG000'}, {'value': '1406', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Risk Placebo', 'description': 'Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to low risk group for developing MCI-AD for up to 5 years.'}, {'id': 'OG001', 'title': 'High Risk Placebo', 'description': 'Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '905.44', 'groupId': 'OG000', 'lowerLimit': '189.00', 'upperLimit': '909.00'}, {'value': '1238.67', 'groupId': 'OG001', 'lowerLimit': '168.00', 'upperLimit': '1268.00'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to the end of study (approximately up to 5 years)', 'description': 'The event definition for MCI-AD was the time in days from the randomization date to the date of the first of two consecutive scheduled visits at which a participant was assessed with a diagnosis of MCI due to AD confirmed by adjudication committee. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to the largest event time.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all participants who were randomized, received at least 1 dose of study drug, and at least 1 valid postbaseline value for assessment of primary efficacy. A participant who does not have an event of MCI due to AD was censored at the date of the last visit at which MCI due to AD could have been assessed.'}, {'type': 'PRIMARY', 'title': 'Time to Diagnosis of MCI Due to AD for Pioglitazone-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, High-risk, Non-Hispanic/Latino, Caucasian Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1406', 'groupId': 'OG000'}, {'value': '1430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Placebo', 'description': 'Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.'}, {'id': 'OG001', 'title': 'High Risk Pioglitazone', 'description': 'Pioglitazone 0.8 mg, sustained release (SR) tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '1238.67', 'groupId': 'OG000', 'lowerLimit': '168.00', 'upperLimit': '1268.00'}, {'value': '1261.24', 'groupId': 'OG001', 'lowerLimit': '168.00', 'upperLimit': '1285.00'}]}]}], 'analyses': [{'pValue': '0.307', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to the end of study (approximately up to 5 years)', 'description': 'The event definition for MCI-AD was the time in days from the randomization date to the date of the first of two consecutive scheduled visits at which a participant was assessed with a diagnosis of MCI due to AD confirmed by adjudication committee. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to the largest event time.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized, received at least 1 dose of study drug, and at least 1 valid postbaseline value for assessment of primary efficacy. A participant who does not have an event of MCI due to AD was censored at the date of the last visit at which MCI due to AD could have been assessed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline for Cognitive Decline on Composite Score on the Cognitive Test Battery for Pioglitazone-treated Participants Versus Placebo-treated Participants in the High-risk Stratum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1406', 'groupId': 'OG000'}, {'value': '1430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Placebo', 'description': 'Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.'}, {'id': 'OG001', 'title': 'High Risk Pioglitazone', 'description': 'Pioglitazone 0.8 mg, sustained release (SR) tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1841', 'spread': '0.27508', 'groupId': 'OG000'}, {'value': '0.1687', 'spread': '0.40621', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 48', 'description': 'Composite scores derived from the test battery. Domains of Episodic Memory \\[California Verbal Learning Test-2nd Edition (CVLT-II), Brief Visuospatial Memory Test-Revised (BVMT-R)\\]; Executive Function \\[Trail Making Test (TMT) (Part B), Wechsler Adult Intelligence Scale (WAIS)-III Digit Span Test-backwards span\\]; Language \\[Multilingual Naming Test (MiNT), Semantic Fluency (animals), Lexical/phonemic fluency (F, A, and S in English; D, S, and F in German)\\]; and Attention \\[WAIS-III Digit Span Test-forward span, TMT (Part A)\\] used for composite score. 12 measures were derived from 8 neuropsychological tests. CVLT-II test involved 2 primary measures (short, long delay recall); BVMT-R had 2 measures (copy and recall); Digit Span and Trail both had 2 measures (forward and backward span and Parts A and B). There was 1 total score for each test: CDT, MINT, semantic and lexical fluency. Total score ranged from -1.222 to 1.707 at baseline, a higher composite score indicated better cognition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized, received at least 1 dose of study drug, and at least 1 valid postbaseline value for assessment of primary efficacy. Number analyzed is the number of participants with evaluable data at the given time-point.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Instrumental Activities of Daily Living (Alzheimer's Disease Cooperative Study Activities of Daily Living - Prevention Instrument [ADCS ADL-PI]) Between Pioglitazone-treated and Placebo-treated Groups of the High-risk Stratum", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1406', 'groupId': 'OG000'}, {'value': '1430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Placebo', 'description': 'Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.'}, {'id': 'OG001', 'title': 'High Risk Pioglitazone', 'description': 'Pioglitazone 0.8 mg, sustained release (SR) tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '4.93', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '5.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 48', 'description': 'The ADCS ADL-PI is a functional measure that was specifically designed for standardized administration over long duration clinical studies to prevent AD. The ADCS ADL-PI is a 20-item instrument that included 15 ADL questions, which were scored as 1 (with a lot of difficulty), 2 (with some difficulty), or 3 (as well as usually, with no difficulty), plus 5 vision, hearing, and mobility questions, which were scored from 0 (no) to 1 (yes). ADL Total ranged from 0 to 45, and lower scores indicated greater disability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized, received at least 1 dose of study drug, and at least 1 valid postbaseline value for assessment of primary efficacy. Number analyzed is the number of participants with evaluable data at the given time-point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Risk Placebo', 'description': 'Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to low risk group for developing MCI-AD for up to 5 years.'}, {'id': 'FG001', 'title': 'High Risk Placebo', 'description': 'Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.'}, {'id': 'FG002', 'title': 'High Risk Pioglitazone', 'description': 'Pioglitazone 0.8 mg, sustained release (SR) tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '433'}, {'groupId': 'FG001', 'numSubjects': '1516'}, {'groupId': 'FG002', 'numSubjects': '1545'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '427'}, {'groupId': 'FG001', 'numSubjects': '1507'}, {'groupId': 'FG002', 'numSubjects': '1531'}]}, {'type': 'COMPLETED', 'comment': 'Completed here refers to those participants who completed study drug.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '429'}, {'groupId': 'FG001', 'numSubjects': '1476'}, {'groupId': 'FG002', 'numSubjects': '1506'}]}], 'dropWithdraws': [{'type': 'Randomized But Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '167'}, {'groupId': 'FG002', 'numSubjects': '132'}]}, {'type': 'Major Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'Voluntary Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '245'}, {'groupId': 'FG002', 'numSubjects': '225'}]}, {'type': 'Study Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '289'}, {'groupId': 'FG001', 'numSubjects': '968'}, {'groupId': 'FG002', 'numSubjects': '1037'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 57 investigative sites in United States, United Kingdom, Germany, Australia, and Switzerland from 01 Aug 2013 to 06 Sep 2018.', 'preAssignmentDetails': 'Participants at least 65 years old with normal cognitive function were enrolled to receive either pioglitazone (0.8 mg sustained release tablet) or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'BG000'}, {'value': '1516', 'groupId': 'BG001'}, {'value': '1545', 'groupId': 'BG002'}, {'value': '3494', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Risk Placebo', 'description': 'Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to low risk group for developing MCI-AD for up to 5 years.'}, {'id': 'BG001', 'title': 'High Risk Placebo', 'description': 'Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.'}, {'id': 'BG002', 'title': 'High Risk Pioglitazone', 'description': 'Pioglitazone 0.8 mg, sustained release (SR) tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.3', 'spread': '4.02', 'groupId': 'BG000'}, {'value': '74.6', 'spread': '5.27', 'groupId': 'BG001'}, {'value': '74.4', 'spread': '5.25', 'groupId': 'BG002'}, {'value': '74.0', 'spread': '5.31', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '<75 years', 'measurements': [{'value': '360', 'groupId': 'BG000'}, {'value': '632', 'groupId': 'BG001'}, {'value': '658', 'groupId': 'BG002'}, {'value': '1650', 'groupId': 'BG003'}]}, {'title': '>=75 years', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '884', 'groupId': 'BG001'}, {'value': '887', 'groupId': 'BG002'}, {'value': '1844', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '259', 'groupId': 'BG000'}, {'value': '850', 'groupId': 'BG001'}, {'value': '812', 'groupId': 'BG002'}, {'value': '1921', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '666', 'groupId': 'BG001'}, {'value': '733', 'groupId': 'BG002'}, {'value': '1573', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '425', 'groupId': 'BG000'}, {'value': '1497', 'groupId': 'BG001'}, {'value': '1533', 'groupId': 'BG002'}, {'value': '3455', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '421', 'groupId': 'BG000'}, {'value': '1463', 'groupId': 'BG001'}, {'value': '1484', 'groupId': 'BG002'}, {'value': '3368', 'groupId': 'BG003'}]}, {'title': 'Multiracial', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Non-Hispanic/Latino Caucasian', 'measurements': [{'value': '413', 'groupId': 'BG000'}, {'value': '1444', 'groupId': 'BG001'}, {'value': '1472', 'groupId': 'BG002'}, {'value': '3329', 'groupId': 'BG003'}]}, {'title': 'Hispanic/Latino and/or non-Caucasian', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '165', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '270', 'groupId': 'BG000'}, {'value': '962', 'groupId': 'BG001'}, {'value': '985', 'groupId': 'BG002'}, {'value': '2217', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '311', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}, {'value': '728', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}, {'value': '489', 'groupId': 'BG003'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized Set included all participants who were randomized in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-27', 'size': 1531454, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-07-22T10:24', 'hasProtocol': True}, {'date': '2017-11-30', 'size': 879041, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-07-22T10:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3494}}, 'statusModule': {'whyStopped': 'Lack of efficacy of the drug; no safety concern', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-29', 'studyFirstSubmitDate': '2013-08-26', 'resultsFirstSubmitDate': '2019-07-22', 'studyFirstSubmitQcDate': '2013-08-26', 'lastUpdatePostDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-22', 'studyFirstPostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Time to Diagnosis of Mild Cognitive Impairment Due to Alzheimer's Disease (MCI-AD) for Placebo-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, Low-risk, Non-Hispanic/Latino Caucasian Participants", 'timeFrame': 'Baseline to the end of study (approximately up to 5 years)', 'description': 'The event definition for MCI-AD was the time in days from the randomization date to the date of the first of two consecutive scheduled visits at which a participant was assessed with a diagnosis of MCI due to AD confirmed by adjudication committee. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to the largest event time.'}, {'measure': 'Time to Diagnosis of MCI Due to AD for Pioglitazone-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, High-risk, Non-Hispanic/Latino, Caucasian Participants', 'timeFrame': 'Baseline to the end of study (approximately up to 5 years)', 'description': 'The event definition for MCI-AD was the time in days from the randomization date to the date of the first of two consecutive scheduled visits at which a participant was assessed with a diagnosis of MCI due to AD confirmed by adjudication committee. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to the largest event time.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline for Cognitive Decline on Composite Score on the Cognitive Test Battery for Pioglitazone-treated Participants Versus Placebo-treated Participants in the High-risk Stratum', 'timeFrame': 'Baseline and Month 48', 'description': 'Composite scores derived from the test battery. Domains of Episodic Memory \\[California Verbal Learning Test-2nd Edition (CVLT-II), Brief Visuospatial Memory Test-Revised (BVMT-R)\\]; Executive Function \\[Trail Making Test (TMT) (Part B), Wechsler Adult Intelligence Scale (WAIS)-III Digit Span Test-backwards span\\]; Language \\[Multilingual Naming Test (MiNT), Semantic Fluency (animals), Lexical/phonemic fluency (F, A, and S in English; D, S, and F in German)\\]; and Attention \\[WAIS-III Digit Span Test-forward span, TMT (Part A)\\] used for composite score. 12 measures were derived from 8 neuropsychological tests. CVLT-II test involved 2 primary measures (short, long delay recall); BVMT-R had 2 measures (copy and recall); Digit Span and Trail both had 2 measures (forward and backward span and Parts A and B). There was 1 total score for each test: CDT, MINT, semantic and lexical fluency. Total score ranged from -1.222 to 1.707 at baseline, a higher composite score indicated better cognition.'}, {'measure': "Change From Baseline in Instrumental Activities of Daily Living (Alzheimer's Disease Cooperative Study Activities of Daily Living - Prevention Instrument [ADCS ADL-PI]) Between Pioglitazone-treated and Placebo-treated Groups of the High-risk Stratum", 'timeFrame': 'Baseline and Month 48', 'description': 'The ADCS ADL-PI is a functional measure that was specifically designed for standardized administration over long duration clinical studies to prevent AD. The ADCS ADL-PI is a 20-item instrument that included 15 ADL questions, which were scored as 1 (with a lot of difficulty), 2 (with some difficulty), or 3 (as well as usually, with no difficulty), plus 5 vision, hearing, and mobility questions, which were scored from 0 (no) to 1 (yes). ADL Total ranged from 0 to 45, and lower scores indicated greater disability.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ["Mild Cognitive Impairment Due to Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '37874111', 'type': 'DERIVED', 'citation': "Zou H, Luo S, Liu H, Lutz MW, Bennett DA, Plassman BL, Welsh-Bohmer KA. Genotypic Effects of the TOMM40'523 Variant and APOE on Longitudinal Cognitive Change over 4 Years: The TOMMORROW Study. J Prev Alzheimers Dis. 2023;10(4):886-894. doi: 10.14283/jpad.2023.115."}, {'pmid': '34146512', 'type': 'DERIVED', 'citation': "Burns DK, Alexander RC, Welsh-Bohmer KA, Culp M, Chiang C, O'Neil J, Evans RM, Harrigan P, Plassman BL, Burke JR, Wu J, Lutz MW, Haneline S, Schwarz AJ, Schneider LS, Yaffe K, Saunders AM, Ratti E; TOMMORROW study investigators. Safety and efficacy of pioglitazone for the delay of cognitive impairment in people at risk of Alzheimer's disease (TOMMORROW): a prognostic biomarker study and a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2021 Jul;20(7):537-547. doi: 10.1016/S1474-4422(21)00043-0."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to qualify the biomarker risk algorithm for prognosis of the risk of developing Mild Cognitive Impairment due to Alzheimer's Disease (MCI-AD), and also to evaluate the efficacy of pioglitazone compared with placebo to delay the onset of MCI-AD in cognitively-normal participants who are at high-risk for developing MCI within 5 years.", 'detailedDescription': "This study has two goals. One of these goals is to see if a new genetic test can determine if participants are at risk of developing Mild Cognitive Impairment due to Alzheimer's Disease (MCI-AD) within the next five years. The other goal is to evaluate the study drug called pioglitazone. Pioglitazone is being tested to delay the onset of MCI-AD. This study will look at the effectiveness of pioglitazone in delaying the onset of MCI-AD in cognitively-normal people who are at high-risk of developing MCI-AD, as identified by the biomarker in the non-Hispanic/Latino Caucasian participants.\n\nThis multi-centre trial will be conducted worldwide. The study will enroll approximately 3500 subjects. Participants will be assigned to high or low risk groups for developing MCI- AD within the next five years, based on the results of the biomarker risk algorithm. Participants in the high risk group will be randomly assigned to one of the two treatment groups-which will remain unknown to the participant and study doctor during the study (unless there is an urgent medical need):\n\n* Pioglitazone tablet\n* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.\n\nParticipants in the low risk group will be assigned to placebo. The assignment of each participant to the high or low risk group, as well as the participant's treatment assignment, will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need).\n\nAll participants will be asked to take one tablet at the same time each day throughout the study.\n\nThe overall time to participate in this study is approximately 5 years. Participants will make up to 14 visits to the clinic, and will be contacted by telephone 3 months after each treatment visit for a follow-up assessment, and 2 weeks after the final visit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '83 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. In the opinion of the investigator, participant is capable of understanding and complying with protocol requirements.\n2. Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.\n3. Is able to physically perform the cognitive tests in the opinion of the investigator and is fluent in the language that tests will be administered.\n4. Is cognitively normal at baseline, scoring as indicated for the following tests:\n\n * Clinical Dementia Rating (CDR)=0.\n * At least one memory test above -1.5 standard deviation (SD) of the demographically corrected normative mean.\n5. Must score ≥25 on the Mini-Mental State Examination (MMSE) at the screening visit after the education and age adjustment.\n6. Is male or postmenopausal female between the ages of 65 and 83 years, inclusive, at time of the Screening visit.\n7. Has the ability and intention to participate in regular study visits, in the opinion of the Investigator.\n8. Has a project partner who can separately complete an Acknowledgement Form on his/her own behalf and take part in the study (with the intent to do so as long as the participant is enrolled) to provide information on the cognitive, functional, and behavioral status of the participant and to assist with monitoring of study medication, if needed.\n\nExclusion Criteria:\n\n1. Has a current diagnosis or history of any type of cognitive impairment or dementia or has a current diagnosis or history of neurological/psychiatric disorder or any other diagnosis that significantly affects cognitive performance (eg, mental retardation, organic mental disorder).\n2. Has a current diagnosis of significant psychiatric illness, per Diagnostic \\& Statistical Manual of Mental Disorders, 4th Edition - Text Revision (DSM-IV-TR) (or DSM-V when published) (including but not limited to major depressive disorder, anxiety disorders) and is in an acute phase/episode, or the participant has a current diagnosis or history of schizophrenia or bipolar disorder.\n3. Has a glycosylated hemoglobin (HbA1c) \\>8.0% at the time of baseline or requires treatment with insulin, triple oral antidiabetic therapy or a peroxisome proliferator-activated receptor-gamma (PPAR-γ) agonist. The participant should be on a stable antidiabetic regimen for at least 3 months prior to enrollment.\n4. Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or cardiovascular, pulmonary, gastrointestinal (including s/p gastric bypass), endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance. History of HIV infection is considered exclusionary for this study.\n5. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse/dependence within 2 years prior to the Screening Visit.\n6. Is an immediate family member, testing center employee, or is in a dependent relationship with a testing center employee who is involved in conduct of this study (eg, spouse, parent, child, and sibling) or may consent under duress.\n7. Has a history of hypersensitivity or allergies to pioglitazone or related compounds.\n8. Is required to take excluded medications as specified in the Excluded Medications Section.\n9. Had any of the following values at the Baseline Visit (Visit 2):\n\n 1. A serum total bilirubin value \\>1.5× upper limit of normal (ULN).\n 2. A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value \\>2xULN.\n 3. Unexplained microscopic/macroscopic hematuria on one repeat examinations within 2 weeks of the initial assessment.\n10. Is positive for either Hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibodies at the Baseline Visit (Visit 2).\n11. Has a condition or takes medication that, in the opinion of the Investigator, could interfere with the assessments of safety, tolerability, or efficacy, or prevent the participant from adequately participating in the study or continue for the anticipated duration of the study.\n12. Has received any investigational compound within 30 days prior to screening or 5 half-lives prior to Screening or is currently participating in another study which entails the administration of an investigational or marketed drug, supplement or intervention including, but not limited to diet, exercise, lifestyle or invasive procedure.\n13. Has a history of any cancer that has been in remission for less than 2 years from the Screening Visit. Participants with basal cell or stage I squamous cell carcinoma of the skin will be eligible. Participants with history of bladder cancer are not eligible irrespective of the remission status.\n14. Has a history or current diagnosis of macular edema or macular degeneration.\n15. If female, has a history of postmenopausal fractures with no or minimal trauma (eg, wrist, hip, lumbar or thoracic vertebral fracture).\n16. Has a history or current diagnosis of congestive heart failure (CHF), New York Heart Association Class III-IV.\n17. Has been exposed to the cognitive tests performed in this study within 6 months prior to the Screening Visit, with the exception of the MMSE.\n18. Participant's Translocase of the Outer Mitochondrial Membrane 40 homolog (TOMM40) rs10524523 or apolipoprotein E (APOE) genotypes or APOE phenotype are known by the participant or the study staff participating in this study."}, 'identificationModule': {'nctId': 'NCT01931566', 'acronym': 'TOMMORROW', 'briefTitle': "Biomarker Qualification for Risk of Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease (AD) and Safety and Efficacy Evaluation of Pioglitazone in Delaying Its Onset", 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': "A Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Simultaneously Qualify a Biomarker Algorithm for Prognosis of Risk of Developing Mild Cognitive Impairment Due to Alzheimer's Disease (MCI Due to AD) and to Test the Safety and Efficacy of Pioglitazone (AD-4833 SR 0.8 mg QD) to Delay the Onset of MCI Due to AD in Cognitively Normal Subjects", 'orgStudyIdInfo': {'id': 'AD-4833/TOMM40_301'}, 'secondaryIdInfos': [{'id': '2012-003111-58', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1139-0355', 'type': 'REGISTRY', 'domain': 'WHO UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Low Risk Placebo', 'description': 'Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to low risk group for developing MCI-AD for up to 5 years.', 'interventionNames': ['Drug: Pioglitazone placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'High Risk Placebo', 'description': 'Pioglitazone placebo-matching tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.', 'interventionNames': ['Drug: Pioglitazone placebo']}, {'type': 'EXPERIMENTAL', 'label': 'High Risk Pioglitazone', 'description': 'Pioglitazone 0.8 mg, sustained release (SR) tablets, orally, once daily to participants assigned to high risk group for developing MCI-AD for up to 5 years.', 'interventionNames': ['Drug: Pioglitazone']}], 'interventions': [{'name': 'Pioglitazone', 'type': 'DRUG', 'description': 'Pioglitazone SR tablets', 'armGroupLabels': ['High Risk Pioglitazone']}, {'name': 'Pioglitazone placebo', 'type': 'DRUG', 'description': 'Pioglitazone placebo-matching tablets', 'armGroupLabels': ['High Risk Placebo', 'Low Risk Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'city': 'Lady Lake', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.91749, 'lon': -81.92286}}, {'city': 'Lake Worth', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.61708, 'lon': -80.07231}}, {'city': 'Merritt Island', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.359, 'lon': -80.69}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Elk Grove', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.00725, 'lon': -87.94034}}, {'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Concord', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.40888, 'lon': -80.58158}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 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