Viewing Study NCT03500692

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Ignite Creation Date: 2025-12-24 @ 3:22 PM
Ignite Modification Date: 2025-12-25 @ 1:41 PM
Study NCT ID: NCT03500692
Status: COMPLETED
Last Update Posted: 2024-07-23
First Post: 2018-03-30
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: MitraClip NT System Post-marketing Surveillance Study - Japan
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sripad.bellary@abbott.com', 'phone': '6503531726', 'title': 'Sripad Bellary', 'organization': 'Abbott'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'This section includes Adverse events reported through 3 years. Subject follow-up is complete.', 'eventGroups': [{'id': 'EG000', 'title': 'MitraClip NT System', 'description': 'Percutaneous mitral valve repair using MitraClip NT System\n\nMitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System', 'otherNumAtRisk': 500, 'deathsNumAtRisk': 500, 'otherNumAffected': 25, 'seriousNumAtRisk': 500, 'deathsNumAffected': 163, 'seriousNumAffected': 322}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Chordae Tendinae Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Mitral Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Mitral Valve Prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Mitral Valve Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Atrial Septal Defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Lung Neoplasm Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Peripheral Artery Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Device Deployment Issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Disseminated Intravascular Coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Haemolytic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hypochromic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Aortic Valve Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Atrial Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Atrial Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Atrioventricular Block Complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 241, 'numAffected': 142}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cardiac Tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cardiogenic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Chordae Tendinae Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Coronary Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Intracardiac Thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Mitral Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Mitral Valve Prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Mitral Valve Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Myocardial Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Sinus Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Tricuspid Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Ventricular Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Atrial Septal Defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vertigo Positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': "Basedow's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Breath Odour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastric Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastric Ulcer Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Intestinal Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Oesophageal Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pancreatitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Multi-Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Sudden Cardiac Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bile Duct Stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cholangitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cholecystitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hepatic Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Appendicitis Perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pneumonia Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Psoas Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Staphylococcal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Compression Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Femoral Neck Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Femur Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Humerus Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Lumbar Vertebral Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pelvic Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Rib Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Spinal Cord Injury Cervical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Subdural Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Thoracic Vertebral Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vascular Access Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Venous Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Acute Myeloid Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Colon Cancer Metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gallbladder Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastric Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hepatic Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Lung Neoplasm Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pancreatic Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Renal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Haemorrhagic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hepatic Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hypoglycaemic Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Intracranial Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Ischaemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Interstitial Lung Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Henoch-Schonlein Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cardiac Pacemaker Replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Haemodialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Aortic Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Peripheral Arterial Occlusive Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Peripheral Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Congestive Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Sick Sinus Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Ventricular Dyssynchrony', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Duodenal Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastrointestinal Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Lower Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Device Battery Issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Device Deployment Issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Device Power Source Issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Implant Site Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Sudden Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Device Related Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Tooth Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Heat Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Spinal Compression Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Tendon Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'International Normalised Ratio Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Carcinoma In Situ Of Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Colorectal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastrointestinal Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Metastases To Liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Oesophageal Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Uterine Prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Central Venous Catheterisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Implantable Defibrillator Insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Leg Amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Aortic Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Aortic Valve Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Single Leaflet Device Attachment (SLDA) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '497', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MitraClip NT System', 'description': 'Percutaneous mitral valve repair using MitraClip NT System\n\nMitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System'}], 'classes': [{'categories': [{'measurements': [{'value': '1.21', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 30 Days', 'description': 'SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device', 'unitOfMeasure': 'percentage of SLDAs', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with available data were included for analysis.'}, {'type': 'PRIMARY', 'title': 'No of Participants With Acute Procedural Success (APS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '496', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MitraClip NT System', 'description': 'Percutaneous mitral valve repair using MitraClip NT System\n\nMitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System'}], 'classes': [{'categories': [{'measurements': [{'value': '452', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 7 days (Discharge visit) from Procedure date', 'description': 'APS is defined as resulting MR reduction to ≤ 2+ per echocardiographic assessment.\n\nMitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with available data were used for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MitraClip NT System', 'description': 'Percutaneous mitral valve repair using MitraClip NT System\n\nMitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '500'}]}, {'type': 'COMPLETED', 'comment': '3 - year visit complete', 'achievements': [{'groupId': 'FG000', 'numSubjects': '259'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '241'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '163'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '75'}]}, {'type': 'Termination Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'A total of 500 subjects were enrolled at 40 sites April 2, 2018 to March 31, 2020.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MitraClip NT System', 'description': 'Percutaneous mitral valve repair using MitraClip NT System\n\nMitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '77.92', 'spread': '9.48', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '206', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '294', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '500', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '500', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '156.96', 'spread': '10.02', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '52.05', 'spread': '10.68', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '21.01', 'spread': '3.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Society of Thoracic Surgeons (STS) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11.95', 'spread': '9.66', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The STS score is a validated risk-prediction model for open surgery based on data from the STS National Adult Cardiac Surgery Database. In general, an STS predicted risk of surgical mortality of 4%-8% is considered intermediate risk and 8% or greater is considered high risk. As of November 15, 2018, The Society of Thoracic Surgeons released an updated short-term risk calculator to reflect the latest 2018 adult cardiac surgery risk models. The STS Calculator allows you to calculate a patient's risk of mortality and morbidities for the most commonly performed cardiac surgeries.", 'unitOfMeasure': 'Percentage of Expected Mortality', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cardiovascular History', 'classes': [{'title': 'Dyslipidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '498', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '216', 'groupId': 'BG000'}]}]}, {'title': 'Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000'}]}]}, {'title': 'Prior Transient Ischemic Attack (TIA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Prior Cerebrovascular Accident (CVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '496', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}]}]}, {'title': 'Prior Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}]}]}, {'title': 'Cardiac Arrhythmia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '358', 'groupId': 'BG000'}]}]}, {'title': 'Atrial Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '316', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All available data has been presented.'}, {'title': 'Cardiac Intervention History', 'classes': [{'title': 'Prior Cardiac Surgeries', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}]}]}, {'title': 'Percutaneous Coronary Interventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}]}]}, {'title': 'CRT/CRT-D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '497', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All available data has been reported.'}, {'title': 'Co-Morbidity', 'classes': [{'title': 'Currently Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '498', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}]}]}, {'title': 'Renal Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '497', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '244', 'groupId': 'BG000'}]}]}, {'title': 'Chronic Lung Diesase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}]}]}, {'title': 'Peripheral Artery Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}, {'title': 'Prior Major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Cirrhosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '497', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '498', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All available data has been reported'}, {'title': 'Heart Valve Intervention', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Heart Failure Hospitalization Within 1 year', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '321', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All available data has been reported.'}, {'title': 'Baseline Etiology of Mitral Regurgitation', 'classes': [{'title': 'Degenerative MR Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}]}]}, {'title': 'Functional MR Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '358', 'groupId': 'BG000'}]}]}, {'title': 'Mixed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Effective Regurgitant Orifice Area', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Effective regurgitant orifice area is an important and clinically significant index of regurgitation severity. Effective regurgitant orifice area is calculated by Doppler echocardiography as the ratio of regurgitant volume/regurgitant jet time-velocity integral.', 'unitOfMeasure': 'cm^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data was not available for all the subjects.'}, {'title': 'Regurgitant Volume', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '461', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '58.04', 'spread': '27.61', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.', 'unitOfMeasure': 'mL/beat', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data was not available for all the subjects.'}, {'title': 'Left Ventricular Ejection Fraction (LVEF)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '46.10', 'spread': '14.93', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage Of Ejection Fraction', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All available data has been reported.'}, {'title': 'Left Ventricular End Systolic Volume (LVESV)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '458', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '93.54', 'spread': '64.43', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.', 'unitOfMeasure': 'mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All available data has been reported.'}, {'title': 'Left Ventricular End Diastolic Volume (LVEDV)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '160.26', 'spread': '75.31', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Left Ventricular End Diastolic Volume (LVEDV) as measured by the site. Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.', 'unitOfMeasure': 'mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All available data has been reported.'}, {'title': 'Serum Creatinine', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '498', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.71', 'spread': '1.54', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All available data has been reported.'}, {'title': 'Brain Natriuretic Peptide (BNP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '407', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '567.11', 'spread': '766.67', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All available data has been reported'}, {'title': 'N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6808.17', 'spread': '17329.44', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Pg/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All available data has been reported'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-04', 'size': 613239, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-16T22:51', 'hasProtocol': True}, {'date': '2018-06-25', 'size': 580225, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-21T22:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2018-03-30', 'resultsFirstSubmitDate': '2021-01-18', 'studyFirstSubmitQcDate': '2018-04-10', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-21', 'studyFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Single Leaflet Device Attachment (SLDA) Rate', 'timeFrame': 'up to 30 Days', 'description': 'SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device'}, {'measure': 'No of Participants With Acute Procedural Success (APS)', 'timeFrame': 'up to 7 days (Discharge visit) from Procedure date', 'description': 'APS is defined as resulting MR reduction to ≤ 2+ per echocardiographic assessment.\n\nMitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mitral Valve Regurgitation', 'MitraClip', 'MitraClip NT', 'Japan MitraClip NT Postmarketing Surveillance'], 'conditions': ['Mitral Regurgitation', 'Mitral Valve Regurgitation']}, 'descriptionModule': {'briefSummary': 'The purpose of the MitraClip post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.', 'detailedDescription': 'This study is a prospective, mutli-center, single-arm post-marketing clinical use surveillance study. The Surveillance will consecutively register patients with moderate to severe and severe mitral regurgitation (3+ and 4+ MR) in whom a MitraClip implant was attempted. Patients registered in the AVJ-514 clinical trial who received additional MitraClip procedures will be excluded from the Surveillance.\n\nPatients will be evaluated at Baseline, Procedure, Discharge, 30 days, 1 year, 2 years and 3 years in Japanese medical centers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Post-marketing Surveillance will consecutively register patients with moderate to severe and severe mitral regurgitation (3+ and 4+ MR) in whom a MitraClip implant was attempted.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Refer to MitraClip IFU\n\nExclusion Criteria: Refer to MitraClip IFU'}, 'identificationModule': {'nctId': 'NCT03500692', 'acronym': 'MitraClip NT', 'briefTitle': 'MitraClip NT System Post-marketing Surveillance Study - Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'MitraClip NT System Post -Marketing Surveillance Study', 'orgStudyIdInfo': {'id': '17-519'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MitraClip NT System', 'description': 'Percutaneous mitral valve repair using MitraClip NT System', 'interventionNames': ['Device: MitraClip NT System']}], 'interventions': [{'name': 'MitraClip NT System', 'type': 'DEVICE', 'description': 'Percutaneous mitral valve repair using MitraClip NT System', 'armGroupLabels': ['MitraClip NT System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '461-0045', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Nagoya Heart Center', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '441-8530', 'city': 'Toyohashi', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Toyohashi Heart Center', 'geoPoint': {'lat': 34.76667, 'lon': 137.38333}}, {'zip': '270-2232', 'city': 'Matsudo', 'state': 'Chiba', 'country': 'Japan', 'facility': 'New Tokyo Hospital', 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