Viewing Study NCT00090259

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Ignite Creation Date: 2025-12-24 @ 2:48 PM
Ignite Modification Date: 2026-03-03 @ 3:06 PM
Study NCT ID: NCT00090259
Status: COMPLETED
Last Update Posted: 2024-05-16
First Post: 2004-08-25
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Study to Evaluate Potential Decrease in Hospitalization Events, Time Between Events, and Increasing Longevity in Patients With Symptomatic Heart Failure (0954-948)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019808', 'term': 'Losartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.', 'description': 'In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.', 'eventGroups': [{'id': 'EG000', 'title': 'Losartan 50 mg', 'otherNumAtRisk': 1913, 'otherNumAffected': 1358, 'seriousNumAtRisk': 1913, 'seriousNumAffected': 691}, {'id': 'EG001', 'title': 'Losartan 150 mg', 'otherNumAtRisk': 1921, 'otherNumAffected': 1394, 'seriousNumAtRisk': 1921, 'seriousNumAffected': 710}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 108}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 100}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 130}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 231}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 200}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 92}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 136}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 159}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 82}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 163}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 285}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 153}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 154}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 161}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 159}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 222}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 150}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 167}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 109}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 231}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 222}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 116}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 170}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 195}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 107}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 119}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 160}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 160}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 135}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 121}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 254}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 245}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 116}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 100}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 132}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 179}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 170}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 166}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 152}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 147}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 123}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 178}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Acquired haemophilia with anti FVIII, XI, or XIII', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anaemia macrocytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anaemia megaloblastic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anaemia vitamin B12 deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lymphadenopathy mediastinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nephrogenic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Intracardiac thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Silent myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Muscular dystrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': "Meniere's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Adrenal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 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1921, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hepatitis alcoholic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ischaemic hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, 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'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': "Behcet's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Contrast media allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal 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0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arthritis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bacterial pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bone tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Borrelia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Brain abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Breast 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{'term': 'Gallbladder empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastroenteritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Necrotising fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Osteomyelitis', 'stats': 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infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Peritonitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pharyngeal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 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1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 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'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Postoperative renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Postoperative thoracic procedure complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Postoperative wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Injury, 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poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Suture rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Therapeutic agent toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 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'MedDRA (12.0)'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Folate deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypercreatininaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hyperglycaemic hyperosmolar nonketotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypoglycaemic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypoproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lipomatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Metabolic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Shock hypoglycaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Articular disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Back disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chondrocalcinosis pyrophosphate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chondromalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diabetic amyotrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fibrosis tendinous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gouty arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gouty tophus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Joint lock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Monarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Muscle haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Muscle twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Neck mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Osteolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Polyarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Polymyalgia rheumatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Soft tissue haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Spinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Acute leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Adrenal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 9}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Benign breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Benign pancreatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bile duct cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bladder cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bone cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bone sarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Brain stem glioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Breast cancer stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Breast cancer stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Carcinoid tumour of the caecum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chronic myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Colon cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Colon cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Colon neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Desmoid tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Epiglottic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gallbladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Glioblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haemangioblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hepatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hepatic neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hepatic neoplasm malignant recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': "Hodgkin's disease recurrent", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Large cell carcinoma of the respiratory tract stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Leiomyosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lip and/or oral cavity cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lipoma of breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lung squamous cell carcinoma stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lung squamous cell carcinoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Malignant neoplasm of renal pelvis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Malignant peritoneal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Malignant soft tissue neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Mesothelioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Metastatic bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Metastatic squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Multiple myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nasopharyngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Neoplasm prostate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Neoplasm skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Neuroendocrine carcinoma of the skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Non-small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Oesophageal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ovarian germ cell teratoma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ovarian neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pancreatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pituitary tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Polycythaemia vera', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 16}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Prostatic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Recurrent cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Refractory anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Small cell lung cancer stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Superficial spreading melanoma stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Thymoma malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Tonsil cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Transitional cell cancer of the renal pelvis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Urinary tract neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': "Waldenstrom's macroglobulinaemia", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Amyotrophic lateral sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Brain stem syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cauda equina syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cerebellar syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cerebral artery embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': "Dementia Alzheimer's type", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Facial palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypercapnic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypoglycaemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Intercostal neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Myasthenia gravis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Parkinsonism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Phantom pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Radicular syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 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'Phlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Temporal arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Varicose ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1913, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1921, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1913', 'groupId': 'OG000'}, {'value': '1921', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Losartan 50 mg'}, {'id': 'OG001', 'title': 'Losartan 150 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '889', 'groupId': 'OG000'}, {'value': '828', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.899', 'ciLowerLimit': '0.818', 'ciUpperLimit': '0.988', 'estimateComment': 'Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, region and β-blocker use at randomization'}], 'paramType': 'NUMBER', 'timeFrame': 'Entire follow-up (median = 4.7 years)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1913', 'groupId': 'OG000'}, {'value': '1921', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Losartan 50 mg'}, {'id': 'OG001', 'title': 'Losartan 150 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '1085', 'groupId': 'OG000'}, {'value': '1037', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.068', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.924', 'ciLowerLimit': '0.848', 'ciUpperLimit': '1.006', 'estimateComment': 'Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, region and β-blocker use at randomization'}], 'paramType': 'NUMBER', 'timeFrame': 'Entire follow-up (median = 4.7 years)', 'description': 'Cardiovascular hospitalization is defined as any hospitalization that may be attributed to a cardiovascular cause, including heart failure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Died (Any Cause)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1913', 'groupId': 'OG000'}, {'value': '1921', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Losartan 50 mg'}, {'id': 'OG001', 'title': 'Losartan 150 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '665', 'groupId': 'OG000'}, {'value': '635', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.235', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.936', 'ciLowerLimit': '0.840', 'ciUpperLimit': '1.044', 'estimateComment': 'Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, region and β-blocker use at randomization'}], 'paramType': 'NUMBER', 'timeFrame': 'Entire follow-up (median = 4.7 years)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Were Hospitalized for Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1913', 'groupId': 'OG000'}, {'value': '1921', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Losartan 50 mg'}, {'id': 'OG001', 'title': 'Losartan 150 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '503', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.865', 'ciLowerLimit': '0.762', 'ciUpperLimit': '0.982', 'estimateComment': 'Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, region and β-blocker use at randomization'}], 'paramType': 'NUMBER', 'timeFrame': 'Entire follow-up (median = 4.7 years)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Experienced Cardiovascular Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1913', 'groupId': 'OG000'}, {'value': '1921', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Losartan 50 mg'}, {'id': 'OG001', 'title': 'Losartan 150 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '826', 'groupId': 'OG000'}, {'value': '762', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.892', 'ciLowerLimit': '0.808', 'ciUpperLimit': '0.984', 'estimateComment': 'Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, region and β-blocker use at randomization'}], 'paramType': 'NUMBER', 'timeFrame': 'Entire follow-up (median = 4.7 years)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Losartan 50 mg'}, {'id': 'FG001', 'title': 'Losartan 150 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1913'}, {'groupId': 'FG001', 'numSubjects': '1921'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed follow-up: 963 on drug, 223 off drug, \\& 665 at death (death was considered an endpoint)', 'groupId': 'FG000', 'numSubjects': '1851'}, {'comment': 'Completed follow-up: 1005 on drug, 233 off drug,\\& 635 at death (death was considered an endpoint)', 'groupId': 'FG001', 'numSubjects': '1873'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '48'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Investigator site closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'First patient in: Nov-2001. Last patient out: May-2009. 255 sites in 30 countries participated (Peru , Chile, Columbia, Mexico, Brazil, Belgium, Croatia, France, Germany, Greece, Holland, Italy, Norway, Poland, Russia, Slovenia, Spain, Turkey, UK, Egypt, Lebanon, Morocco, S. Africa, China, Hong Kong, Korea, Malaysia, Philippines, Singapore, Taiwan)', 'preAssignmentDetails': 'Patients who were on a Angiotensin II Antagonist (AIIA) had the option to begin losartan treatment with open-label losartan 12.5 mg for one week followed by losartan 25 mg for one week and were subsequently randomized to losartan 50 mg or losartan 150 mg.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1913', 'groupId': 'BG000'}, {'value': '1921', 'groupId': 'BG001'}, {'value': '3834', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Losartan 50 mg'}, {'id': 'BG001', 'title': 'Losartan 150 mg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.1', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '95'}, {'value': '64.4', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '98'}, {'value': '64.2', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '98'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years of Age', 'categories': [{'measurements': [{'value': '889', 'groupId': 'BG000'}, {'value': '879', 'groupId': 'BG001'}, {'value': '1768', 'groupId': 'BG002'}]}]}, {'title': '>=65 years of Age', 'categories': [{'measurements': [{'value': '1024', 'groupId': 'BG000'}, {'value': '1042', 'groupId': 'BG001'}, {'value': '2066', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '560', 'groupId': 'BG000'}, {'value': '583', 'groupId': 'BG001'}, {'value': '1143', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1353', 'groupId': 'BG000'}, {'value': '1338', 'groupId': 'BG001'}, {'value': '2691', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Angiotensin II antagonists', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '456', 'groupId': 'BG000'}, {'value': '438', 'groupId': 'BG001'}, {'value': '894', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '1457', 'groupId': 'BG000'}, {'value': '1483', 'groupId': 'BG001'}, {'value': '2940', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'New York Heart Association (NYHA) functional status', 'classes': [{'title': 'I No symptoms', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'II Mild symptoms', 'categories': [{'measurements': [{'value': '1330', 'groupId': 'BG000'}, {'value': '1327', 'groupId': 'BG001'}, {'value': '2657', 'groupId': 'BG002'}]}]}, {'title': 'III Marked limitation', 'categories': [{'measurements': [{'value': '569', 'groupId': 'BG000'}, {'value': '583', 'groupId': 'BG001'}, {'value': '1152', 'groupId': 'BG002'}]}]}, {'title': 'IV Severe limitations', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'NYHA Class Symptoms\n\nI No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.\n\nII Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.\n\nIII Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest.\n\nIV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.', 'unitOfMeasure': 'Participants'}, {'title': 'Region', 'classes': [{'title': 'Asia and Pacific Region', 'categories': [{'measurements': [{'value': '391', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '781', 'groupId': 'BG002'}]}]}, {'title': 'East Europe', 'categories': [{'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '419', 'groupId': 'BG002'}]}]}, {'title': 'Middle East and Africa', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}]}, {'title': 'Latin America', 'categories': [{'measurements': [{'value': '309', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '624', 'groupId': 'BG002'}]}]}, {'title': 'West Europe', 'categories': [{'measurements': [{'value': '904', 'groupId': 'BG000'}, {'value': '912', 'groupId': 'BG001'}, {'value': '1816', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'β - Blocker therapy', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '543', 'groupId': 'BG000'}, {'value': '533', 'groupId': 'BG001'}, {'value': '1076', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '1370', 'groupId': 'BG000'}, {'value': '1388', 'groupId': 'BG001'}, {'value': '2758', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3834}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2009-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2004-08-25', 'resultsFirstSubmitDate': '2010-06-30', 'studyFirstSubmitQcDate': '2004-08-26', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-06-30', 'studyFirstPostDateStruct': {'date': '2004-08-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure', 'timeFrame': 'Entire follow-up (median = 4.7 years)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization', 'timeFrame': 'Entire follow-up (median = 4.7 years)', 'description': 'Cardiovascular hospitalization is defined as any hospitalization that may be attributed to a cardiovascular cause, including heart failure.'}, {'measure': 'Number of Participants That Died (Any Cause)', 'timeFrame': 'Entire follow-up (median = 4.7 years)'}, {'measure': 'Number of Participants That Were Hospitalized for Heart Failure', 'timeFrame': 'Entire follow-up (median = 4.7 years)'}, {'measure': 'Number of Participants That Experienced Cardiovascular Hospitalization', 'timeFrame': 'Entire follow-up (median = 4.7 years)'}]}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '27514751', 'type': 'DERIVED', 'citation': 'Upshaw JN, Konstam MA, Klaveren Dv, Noubary F, Huggins GS, Kent DM. Multistate Model to Predict Heart Failure Hospitalizations and All-Cause Mortality in Outpatients With Heart Failure With Reduced Ejection Fraction: Model Derivation and External Validation. Circ Heart Fail. 2016 Aug;9(8):e003146. doi: 10.1161/CIRCHEARTFAILURE.116.003146.'}, {'pmid': '25828348', 'type': 'DERIVED', 'citation': 'Rossignol P, Girerd N, Gregory D, Massaro J, Konstam MA, Zannad F. Increased visit-to-visit blood pressure variability is associated with worse cardiovascular outcomes in low ejection fraction heart failure patients: Insights from the HEAAL study. Int J Cardiol. 2015;187:183-9. doi: 10.1016/j.ijcard.2015.03.169. Epub 2015 Mar 17.'}, {'pmid': '25742759', 'type': 'DERIVED', 'citation': 'Kiernan MS, Gregory D, Sarnak MJ, Rossignol P, Massaro J, Kociol R, Zannad F, Konstam MA. Early and late effects of high- versus low-dose angiotensin receptor blockade on renal function and outcomes in patients with chronic heart failure. JACC Heart Fail. 2015 Mar;3(3):214-23. doi: 10.1016/j.jchf.2014.11.004.'}, {'pmid': '19922995', 'type': 'DERIVED', 'citation': 'Konstam MA, Neaton JD, Dickstein K, Drexler H, Komajda M, Martinez FA, Riegger GA, Malbecq W, Smith RD, Guptha S, Poole-Wilson PA; HEAAL Investigators. Effects of high-dose versus low-dose losartan on clinical outcomes in patients with heart failure (HEAAL study): a randomised, double-blind trial. Lancet. 2009 Nov 28;374(9704):1840-8. doi: 10.1016/S0140-6736(09)61913-9. Epub 2009 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter study to evaluate potential decrease in hospitalization events and time between events and increasing longevity in patients with symptomatic congestive heart failure and intolerant of first-line medication for heart failure. This study will evaluate if higher doses of the investigational drug given daily will be superior to the lower dose of the same investigational drug given daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic heart failure with known or recently diagnosed intolerance of treatment with first-line medication for heart failure\n* May or may not be receiving an alternative and/or additional drug treatment'}, 'identificationModule': {'nctId': 'NCT00090259', 'briefTitle': 'Study to Evaluate Potential Decrease in Hospitalization Events, Time Between Events, and Increasing Longevity in Patients With Symptomatic Heart Failure (0954-948)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Multi-center, Double-Blind, Randomized, Parallel Group Study to Evaluate the Effects of Two Different Doses of Losartan on Morbidity and Mortality in Patients With Symptomatic Heart Failure Intolerant of ACE Inhibitor Treatment', 'orgStudyIdInfo': {'id': '0954-948'}, 'secondaryIdInfos': [{'id': '2004_004'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Losartan 50 mg', 'description': '50-mg losartan tablet administered daily with 1 tablet of 100-mg losartan placebo beginning Week 1 and continuing to end of study (up to 4 years)', 'interventionNames': ['Drug: Losartan 50 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Losartan 150 mg', 'description': 'Titrated losartan administration up to daily 150-mg losartan: Week 1, daily 50-mg losartan tablet coadministered with 100-mg losartan placebo; Week 2, daily 50-mg losartan placebo coadministered with 100-mg losartan; Week 3 to end of study (up to 4 years), daily 50-mg losartan tablet coadministered with 100-mg losartan', 'interventionNames': ['Drug: Losartan 150 mg']}], 'interventions': [{'name': 'Losartan 50 mg', 'type': 'DRUG', 'otherNames': ['Losartan potassium'], 'description': '50-mg losartan oral tablet', 'armGroupLabels': ['Losartan 50 mg']}, {'name': 'Losartan 150 mg', 'type': 'DRUG', 'otherNames': ['Losartan potassium'], 'description': '100-mg losartan oral tablet + 50-mg losartan oral tablet', 'armGroupLabels': ['Losartan 150 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}