Viewing Study NCT00808067

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Ignite Creation Date: 2025-12-25 @ 12:40 AM
Ignite Modification Date: 2025-12-25 @ 10:51 PM
Study NCT ID: NCT00808067
Status: COMPLETED
Last Update Posted: 2014-06-09
First Post: 2008-12-12
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ukraine']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Non-serious adverse events were not collected on subjects in this study.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 43 months', 'eventGroups': [{'id': 'EG000', 'title': 'Dabigatran 110 mg', 'description': 'Dabigatran etexilate 110 mg twice daily', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 2914, 'seriousNumAffected': 1028}, {'id': 'EG001', 'title': 'Dabigatran 150 mg', 'description': 'Dabigatran etexilate 150 mg twice daily', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 2937, 'seriousNumAffected': 1106}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 36}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Heparin-induced thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 36}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 95}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 23}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 87}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 71}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cardiac valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Chronotropic incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': "Dressler's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Mitral valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Sinus arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Tricuspid valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': "Addison's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Amaurosis fugax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Blepharochalasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Blindness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Eye haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 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'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Jaw cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 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'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Polymyalgia rheumatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Pseudarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Benign neoplasm of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Bile duct cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 9}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Bone neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Bone sarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Brain neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 9}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Carcinoid tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Choroid melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Colon cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Colon cancer stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Gallbladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Gastric neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Gastrointestinal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Gastrointestinal tract adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Gastrooesophageal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Glioblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Hepatic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Hepatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Hepatic neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': "Hodgkin's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Keratoacanthoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': "Langerhans' cell histiocytosis", 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Large cell carcinoma of the respiratory tract stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Laryngeal cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Liposarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Lung carcinoma cell type unspecified recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Malignant neoplasm of pleura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Metastases to pelvis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Multiple myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Neoplasm prostate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Neuroendocrine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Non-small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Oesophageal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Pancreatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Parathyroid tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Phaeochromocytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 14}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Prostate cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Rectal cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Rectal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Small cell lung cancer stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Thymoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Thyroid cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Tongue neoplasm malignant stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Ureteric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Vulval cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Brachial plexopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Brain stem stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Carotid artery insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Carotid sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cerebellar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cervical root pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Chronic inflammatory demyelinating polyradiculoneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': "Dementia Alzheimer's type", 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 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'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Sciatic nerve 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'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Vertigo CNS origin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Abnormal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 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subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Pemphigoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Skin discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Skin haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Stasis dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Activities of daily living impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Dental implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Lesion excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Aortic intramural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Blood pressure inadequately controlled', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Femoral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Femoral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Leriche syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Temporal arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Venous occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2914, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2937, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Major Bleeding, Annualized Rate of Subjects With Major Bleeds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2914', 'groupId': 'OG000'}, {'value': '2937', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 110 mg', 'description': 'Dabigatran etexilate 110 mg twice daily'}, {'id': 'OG001', 'title': 'Dabigatran 150 mg', 'description': 'Dabigatran etexilate 150 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.79', 'groupId': 'OG000'}, {'value': '3.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.64', 'ciUpperLimit': '0.93', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.\n\nMajor bleeding must have satisfied one or more of the following criteria:\n\n* Bleeding associated with a reduction in hemoglobin of at least 20 g/L\n* Required transfusion of at least 2 units of blood or packed cells\n* Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal\n\nMajor bleed were classified as life-threatening if they met one or more of the following criteria:\n\n* Reduction in hemoglobin of at least 50 g/L\n* Transfusion of at least 4 units of blood or packed cells\n* Symptomatic intracranial bleeding, either subdural or intracerebral\n* Associated with hypotension requiring use of intravenous inotropic agents\n* Required surgical intervention to stop bleeding\n* Resulted in death', 'unitOfMeasure': 'percentage of subject-years', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF-FAS interval'}, {'type': 'SECONDARY', 'title': 'Stroke, Annualized Rate of Subjects With Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2914', 'groupId': 'OG000'}, {'value': '2937', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 110 mg', 'description': 'Dabigatran etexilate 110 mg twice daily'}, {'id': 'OG001', 'title': 'Dabigatran 150 mg', 'description': 'Dabigatran etexilate 150 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.39', 'groupId': 'OG000'}, {'value': '1.26', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.\n\nStroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital', 'unitOfMeasure': 'percentage of subject-years', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF-FAS interval'}, {'type': 'SECONDARY', 'title': 'Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2914', 'groupId': 'OG000'}, {'value': '2937', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 110 mg', 'description': 'Dabigatran etexilate 110 mg twice daily'}, {'id': 'OG001', 'title': 'Dabigatran 150 mg', 'description': 'Dabigatran etexilate 150 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000'}, {'value': '0.23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.\n\nSystemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy.', 'unitOfMeasure': 'percentage of subject-years', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF-FAS interval'}, {'type': 'SECONDARY', 'title': 'Pulmonary Embolism (PE), Annualized Rate of Subjects With PE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2914', 'groupId': 'OG000'}, {'value': '2937', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 110 mg', 'description': 'Dabigatran etexilate 110 mg twice daily'}, {'id': 'OG001', 'title': 'Dabigatran 150 mg', 'description': 'Dabigatran etexilate 150 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000'}, {'value': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.\n\nPulmonary Embolism was generally documented by one of the following:\n\n1. an intraluminal filling defect in segmental or more proximal branches on spiral CT scan\n2. an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram\n3. a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)\n4. inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography.', 'unitOfMeasure': 'percentage of subject-years', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF-FAS interval'}, {'type': 'SECONDARY', 'title': 'Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2914', 'groupId': 'OG000'}, {'value': '2937', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 110 mg', 'description': 'Dabigatran etexilate 110 mg twice daily'}, {'id': 'OG001', 'title': 'Dabigatran 150 mg', 'description': 'Dabigatran etexilate 150 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000'}, {'value': '0.66', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.\n\na. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy.', 'unitOfMeasure': 'percentage of subject-years', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF-FAS interval'}, {'type': 'SECONDARY', 'title': 'Deep Vein Thrombosis, Annualized Rate of Subjects With DVT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2914', 'groupId': 'OG000'}, {'value': '2937', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 110 mg', 'description': 'Dabigatran etexilate 110 mg twice daily'}, {'id': 'OG001', 'title': 'Dabigatran 150 mg', 'description': 'Dabigatran etexilate 150 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000'}, {'value': '0.11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.\n\nDeep Vein Thrombosis (DVT) was generally documented by one of the following:\n\n1. abnormal compression ultrasound (CUS),\n2. an intraluminal filling defect on venography.', 'unitOfMeasure': 'percentage of subject-years', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF-FAS interval'}, {'type': 'SECONDARY', 'title': 'Death, Annualized Rate of Subject Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2914', 'groupId': 'OG000'}, {'value': '2937', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 110 mg', 'description': 'Dabigatran etexilate 110 mg twice daily'}, {'id': 'OG001', 'title': 'Dabigatran 150 mg', 'description': 'Dabigatran etexilate 150 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3.18', 'groupId': 'OG000'}, {'value': '2.99', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.\n\nDeaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology.', 'unitOfMeasure': 'percentage of subject-years', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF-FAS interval'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2914', 'groupId': 'OG000'}, {'value': '2937', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 110 mg', 'description': 'Dabigatran etexilate 110 mg twice daily'}, {'id': 'OG001', 'title': 'Dabigatran 150 mg', 'description': 'Dabigatran etexilate 150 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.60', 'groupId': 'OG000'}, {'value': '1.47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5119', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.42', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.', 'unitOfMeasure': 'percentage of subject-years', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF-FAS interval'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2914', 'groupId': 'OG000'}, {'value': '2937', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 110 mg', 'description': 'Dabigatran etexilate 110 mg twice daily'}, {'id': 'OG001', 'title': 'Dabigatran 150 mg', 'description': 'Dabigatran etexilate 150 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '4.40', 'groupId': 'OG000'}, {'value': '4.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2371', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.29', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.', 'unitOfMeasure': 'percentage of subject-years', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF-FAS interval'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2914', 'groupId': 'OG000'}, {'value': '2937', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 110 mg', 'description': 'Dabigatran etexilate 110 mg twice daily'}, {'id': 'OG001', 'title': 'Dabigatran 150 mg', 'description': 'Dabigatran etexilate 150 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3.51', 'groupId': 'OG000'}, {'value': '3.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5052', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.27', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.', 'unitOfMeasure': 'percentage of subject-years', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF-FAS interval'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2914', 'groupId': 'OG000'}, {'value': '2937', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 110 mg', 'description': 'Dabigatran etexilate 110 mg twice daily'}, {'id': 'OG001', 'title': 'Dabigatran 150 mg', 'description': 'Dabigatran etexilate 150 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '6.65', 'groupId': 'OG000'}, {'value': '7.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2241', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.05', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.', 'unitOfMeasure': 'percentage of subject-years', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF-FAS interval'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of Subjects With Minor Bleeds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2914', 'groupId': 'OG000'}, {'value': '2937', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 110 mg', 'description': 'Dabigatran etexilate 110 mg twice daily'}, {'id': 'OG001', 'title': 'Dabigatran 150 mg', 'description': 'Dabigatran etexilate 150 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '7.49', 'groupId': 'OG000'}, {'value': '8.98', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.\n\nMinor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not.', 'unitOfMeasure': 'percentage of subject-years', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF-FAS interval'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2914', 'groupId': 'OG000'}, {'value': '2937', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 110 mg', 'description': 'Dabigatran etexilate 110 mg twice daily'}, {'id': 'OG001', 'title': 'Dabigatran 150 mg', 'description': 'Dabigatran etexilate 150 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '9.44', 'groupId': 'OG000'}, {'value': '11.20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.', 'unitOfMeasure': 'percentage of subject-years', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF-FAS interval'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2914', 'groupId': 'OG000'}, {'value': '2937', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 110 mg', 'description': 'Dabigatran etexilate 110 mg twice daily'}, {'id': 'OG001', 'title': 'Dabigatran 150 mg', 'description': 'Dabigatran etexilate 150 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000'}, {'value': '0.33', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.', 'unitOfMeasure': 'percentage of subject-years', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF-FAS interval'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dabigatran 110 mg', 'description': 'Dabigatran etexilate 110 mg twice daily'}, {'id': 'FG001', 'title': 'Dabigatran 150 mg', 'description': 'Dabigatran etexilate 150 mg twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number of patients which are treated.', 'groupId': 'FG000', 'numSubjects': '2927'}, {'comment': 'Number of patients which are treated.', 'groupId': 'FG001', 'numSubjects': '2956'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2446'}, {'groupId': 'FG001', 'numSubjects': '2438'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '481'}, {'groupId': 'FG001', 'numSubjects': '518'}]}], 'dropWithdraws': [{'type': 'Major/minor bleed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'Outcome event - other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '121'}]}, {'type': 'Hospitalization (not including surgery)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Hospitalization due to surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'Reduced creatinine clearance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'Elevated LFT results', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Patient refused to take study medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Site closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Patient elected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Site closed for cause', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Other reason not defined above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Excluded from analysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '19'}]}]}], 'preAssignmentDetails': "A total of 5897 subjects were enrolled (rolled over from RE-LY trial), and 5891 were entered in this study. There were 8 subjects not treated; therefore 5883 subjects comprise the 'started' treatment group."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2914', 'groupId': 'BG000'}, {'value': '2937', 'groupId': 'BG001'}, {'value': '5851', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dabigatran 110 mg', 'description': 'Dabigatran etexilate 110 mg twice daily'}, {'id': 'BG001', 'title': 'Dabigatran 150 mg', 'description': 'Dabigatran etexilate 150 mg twice daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.1', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '73.1', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '73.1', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1000', 'groupId': 'BG000'}, {'value': '1026', 'groupId': 'BG001'}, {'value': '2026', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1914', 'groupId': 'BG000'}, {'value': '1911', 'groupId': 'BG001'}, {'value': '3825', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'SAF - Safety set; included all treated subjects, but excluded subjects from sites 1059 and 0246.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5897}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-03', 'studyFirstSubmitDate': '2008-12-12', 'resultsFirstSubmitDate': '2013-12-20', 'studyFirstSubmitQcDate': '2008-12-12', 'lastUpdatePostDateStruct': {'date': '2014-06-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-03', 'studyFirstPostDateStruct': {'date': '2008-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Bleeding, Annualized Rate of Subjects With Major Bleeds', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.\n\nMajor bleeding must have satisfied one or more of the following criteria:\n\n* Bleeding associated with a reduction in hemoglobin of at least 20 g/L\n* Required transfusion of at least 2 units of blood or packed cells\n* Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal\n\nMajor bleed were classified as life-threatening if they met one or more of the following criteria:\n\n* Reduction in hemoglobin of at least 50 g/L\n* Transfusion of at least 4 units of blood or packed cells\n* Symptomatic intracranial bleeding, either subdural or intracerebral\n* Associated with hypotension requiring use of intravenous inotropic agents\n* Required surgical intervention to stop bleeding\n* Resulted in death'}], 'secondaryOutcomes': [{'measure': 'Stroke, Annualized Rate of Subjects With Stroke', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.\n\nStroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital'}, {'measure': 'Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.\n\nSystemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy.'}, {'measure': 'Pulmonary Embolism (PE), Annualized Rate of Subjects With PE', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.\n\nPulmonary Embolism was generally documented by one of the following:\n\n1. an intraluminal filling defect in segmental or more proximal branches on spiral CT scan\n2. an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram\n3. a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)\n4. inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography.'}, {'measure': 'Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.\n\na. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy.'}, {'measure': 'Deep Vein Thrombosis, Annualized Rate of Subjects With DVT', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.\n\nDeep Vein Thrombosis (DVT) was generally documented by one of the following:\n\n1. abnormal compression ultrasound (CUS),\n2. an intraluminal filling defect on venography.'}, {'measure': 'Death, Annualized Rate of Subject Death', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.\n\nDeaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology.'}, {'measure': 'Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.'}, {'measure': 'Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.'}, {'measure': 'Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.'}, {'measure': 'Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.'}, {'measure': 'Annualized Rate of Subjects With Minor Bleeds', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.\n\nMinor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not.'}, {'measure': 'Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.'}, {'measure': 'Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)', 'timeFrame': 'up to 43 months', 'description': 'Annualized event rate (%) = 100 \\* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.'}]}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '23770747', 'type': 'DERIVED', 'citation': 'Connolly SJ, Wallentin L, Ezekowitz MD, Eikelboom J, Oldgren J, Reilly PA, Brueckmann M, Pogue J, Alings M, Amerena JV, Avezum A, Baumgartner I, Budaj AJ, Chen JH, Dans AL, Darius H, Di Pasquale G, Ferreira J, Flaker GC, Flather MD, Franzosi MG, Golitsyn SP, Halon DA, Heidbuchel H, Hohnloser SH, Huber K, Jansky P, Kamensky G, Keltai M, Kim SS, Lau CP, Le Heuzey JY, Lewis BS, Liu L, Nanas J, Omar R, Pais P, Pedersen KE, Piegas LS, Raev D, Smith PJ, Talajic M, Tan RS, Tanomsup S, Toivonen L, Vinereanu D, Xavier D, Zhu J, Wang SQ, Duffy CO, Themeles E, Yusuf S. The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study. Circulation. 2013 Jul 16;128(3):237-43. doi: 10.1161/CIRCULATIONAHA.112.001139. Epub 2013 Jun 14.'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are:\n\n1. To evaluate the long-term safety of dabigatran etexilate\n2. To assess the effect of a knowledge translation intervention on patient outcomes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nParticipation in RE-LY, requires long term anticoagulation, provides written informed consent\n\nExclusion criteria:\n\nPermanent discontinuation of dabigatran during RE-LY'}, 'identificationModule': {'nctId': 'NCT00808067', 'briefTitle': 'RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed the RE-LY Trial and a Cluster Randomised Trial to Assess the Effect of a Knowledge Translation Intervention on Patient Outcomes', 'orgStudyIdInfo': {'id': 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