Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT01240902
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2010-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rs.medtroniccardiovascularclinicaltrials@medtronic.com', 'title': 'Hatice Bilgic Lim', 'organization': 'Medtronic, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year', 'description': 'All new or worsening AEs were collected through12 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access', 'otherNumAtRisk': 489, 'otherNumAffected': 440, 'seriousNumAtRisk': 489, 'seriousNumAffected': 452}, {'id': 'EG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access', 'otherNumAtRisk': 150, 'otherNumAffected': 139, 'seriousNumAtRisk': 150, 'seriousNumAffected': 142}, {'id': 'EG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)', 'otherNumAtRisk': 390, 'otherNumAffected': 355, 'seriousNumAtRisk': 390, 'seriousNumAffected': 346}, {'id': 'EG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)', 'otherNumAtRisk': 357, 'otherNumAffected': 320, 'seriousNumAtRisk': 357, 'seriousNumAffected': 324}], 'otherEvents': [{'term': 'Anaemias Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 98, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 77, 'numAffected': 76}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 78, 'numAffected': 69}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Leukocytoses Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 42, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 49, 'numAffected': 46}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thrombocytopenias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 73, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 33, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 64, 'numAffected': 61}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 95, 'numAffected': 90}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac Conduction Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 137, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 37, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 100, 'numAffected': 80}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 68, 'numAffected': 54}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Heart Failures Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 32, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rate And Rhythm Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 30, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 31, 'numAffected': 30}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Supraventricular Arrhythmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 66, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 42, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 69, 'numAffected': 59}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 91, 'numAffected': 80}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ventricular Arrhythmias And Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 33, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrointestinal Atonic And Hypomotility Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 37, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea And Vomiting Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 33, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 21, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Febrile Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 39, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oedema Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 48, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 35, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 31, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain And Discomfort Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 34, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 33, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lower Respiratory Tract And Lung Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary Tract Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 80, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 34, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 59, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 67, 'numAffected': 58}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Non-Site Specific Injuries Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Non-Site Specific Procedural Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Skeletal And Cardiac Muscle Analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyperglycaemic Conditions Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 30, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Magnesium Metabolism Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Potassium Imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 63, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 25, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 38, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 37, 'numAffected': 33}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sodium Imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 29, 'numAffected': 28}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Total Fluid Volume Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 43, 'numAffected': 41}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Musculoskeletal And Connective Tissue Pain And Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 42, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 39, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neurological Signs And Symptoms Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 21, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anxiety Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Confusion And Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 34, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 25, 'numAffected': 23}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal Failure And Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 78, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 43, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 51, 'numAffected': 44}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Breathing Abnormalities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchospasm And Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Conditions Associated With Abnormal Gas Exchange', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Parenchymal Lung Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 41, 'numAffected': 41}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumothorax And Pleural Effusions Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 82, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 32, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 58, 'numAffected': 52}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 105, 'numAffected': 91}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary Oedemas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 27, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haemorrhages Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 35, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vascular Hypertensive Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 49, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 55, 'numAffected': 46}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 40, 'numAffected': 37}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vascular Hypotensive Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 73, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 41, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 43, 'numAffected': 40}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Anaemia Deficiencies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anaemias Due To Chronic Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anaemias Haemolytic Immune', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anaemias Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 170, 'numAffected': 140}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 75, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 132, 'numAffected': 106}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 173, 'numAffected': 151}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Coagulopathies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Eosinophilic Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and 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'MedDRA 14.1'}, {'term': 'Colitis (Excl Infective)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diaphragmatic Hernias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea (Excl Infective)', 'stats': 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'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Duodenal Ulcers And Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspeptic Signs And Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 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'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intestinal Ulcers And Perforation Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea And Vomiting Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Non-Site Specific Gastrointestinal Haemorrhages', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 40, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oesophageal Stenosis And Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oesophageal Ulcers And Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oesophagitis (Excl Infective)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oral Soft Tissue Pain And Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pancreatic Neoplasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Peritoneal And Retroperitoneal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Peritoneal And Retroperitoneal Haemorrhages', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Umbilical Hernias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Administration Site Reactions Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthenic Conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Body Temperature Altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac Complications Associated With Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Complications Associated With Device Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Death And Sudden Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 390, 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'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Febrile Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Feelings And Sensations Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gait Disturbances', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'General Signs And Symptoms Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Healing Abnormal Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hernias Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Implant And Catheter Site Reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 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'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Enterococcal Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Escherichia Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fungal Infections Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haemophilus Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Herpes Viral Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Infections Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Infectious Transmissions', 'stats': [{'groupId': 'EG000', 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{'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lower Respiratory Tract And Lung Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 95, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 48, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 43, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pseudomonal Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sepsis, Bacteraemia, Viraemia And Fungaemia Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 35, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 38, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 36, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Staphylococcal Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Streptococcal Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper Respiratory Tract Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary Tract Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 32, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vascular Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Viral Infections Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anaesthetic Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac And Vascular Procedural Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiovascular Injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cerebral Injuries Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chest And Lung Injuries Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fractures And Dislocations Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrointestinal And Hepatobiliary Procedural Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Limb Injuries Nec (Incl Traumatic Amputation)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lower Limb Fractures And Dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Non-Site Specific Injuries Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Non-Site Specific Procedural Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 29, 'numAffected': 28}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pelvic Fractures And Dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Poisoning And Toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Radiation Injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Reproductive System And Breast Injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory Tract And Thoracic Cavity Procedural Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Site Specific Injuries Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Skin Injuries Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Skin Procedural Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Skull Fractures, Facial Bone Fractures And Dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Spinal Fractures And Dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thoracic Cage Fractures And Dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Transfusion Related Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper Limb Fractures And Dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bacteria Identification And Serology (Excl Mycobacteria)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Blood Counts Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Blood Gas And Acid Base Analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Carbohydrate Tolerance Analyses (Incl Diabetes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac Function Diagnostic Procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Coagulation And Bleeding Analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ecg Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Liver Function Analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Metabolism Tests Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Microbiology And Serology Tests Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mineral And Electrolyte Analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Physical Examination Procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Platelet Analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Protein Analyses Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Red Blood Cell Analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal Function Analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory Tract And Thoracic Imaging Procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Skeletal And Cardiac Muscle Analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tissue Enzyme Analyses Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinalysis Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary Tract Function Analyses Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vascular Tests Nec (Incl Blood Pressure)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'White Blood Cell Analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Appetite Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Calcium Metabolism Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diabetes Mellitus (Incl Subtypes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diabetic Complications Dermal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diabetic Complications Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Disorders Of Purine Metabolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Electrolyte Imbalance Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'General Nutritional Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyperglycaemic Conditions Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoglycaemic Conditions Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Magnesium Metabolism Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Metabolic Acidoses (Excl Diabetic Acidoses)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Metabolic Alkaloses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mixed Acid-Base Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Potassium Imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Protein Metabolism Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sodium Imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Total Fluid Volume Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Total Fluid Volume Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthropathies Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bone Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bone Related Signs And Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Joint Related Signs And Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Metabolic Bone Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Muscle Weakness Conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Musculoskeletal And Connective Tissue Pain And Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Musculoskeletal And Connective Tissue Signs And Symptoms Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myopathies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Osteoarthropathies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Spine And Neck Deformities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'B-Cell Lymphomas Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bladder Neoplasms Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Breast And Nipple Neoplasms Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Colonic Neoplasms Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastric Neoplasms Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrointestinal Neoplasms Malignancy Unspecified Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hepatic Neoplasms Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Leukaemias Acute Myeloid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Multiple Myelomas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myelodysplastic Syndromes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neoplasms Malignant Site Unspecified Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neuromas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pancreatic Neoplasms Malignant (Excl Islet Cell And Carcinoid)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pharyngeal And Laryngeal Neoplasms Benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Prostatic Neoplasms Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal Neoplasms Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, 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'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thyroid Neoplasms Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acute Polyneuropathies', 'stats': [{'groupId': 'EG000', 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'EG000', 'numAtRisk': 489, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cerebellar Coordination And Balance Disturbances', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Coma States', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cortical Dysfunction Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': "Dementia (Excl Alzheimer's Type)", 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Disturbances In Consciousness Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyskinesias And Movement Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Encephalopathies Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Encephalopathies Toxic And Metabolic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headaches Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hydrocephalic Conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Increased Intracranial Pressure Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lumbar Spinal Cord And Nerve Root Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Memory Loss (Excl Dementia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Migraine Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mononeuropathies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nervous System Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neurological Signs And Symptoms Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neuromuscular Junction Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Paralysis And Paresis (Excl Cranial Nerve)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Peripheral Neuropathies Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Seizures And Seizure Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sensory Abnormalities Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Speech And Language Abnormalities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Transient Cerebrovascular Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tremor (Excl Congenital)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 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'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasal Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Parenchymal Lung Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 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Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Peripheral Aneurysms And Dissections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Peripheral Embolism And Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Peripheral Vascular Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Site Specific Vascular Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Varicose Veins Non-Site Specific', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vascular Hypertensive Disorders Nec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vascular Hypotensive Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 54, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 40, 'numAffected': 38}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vascular Malformations And Acquired Anomalies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}, {'value': '359', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000'}, {'value': '39.3', 'groupId': 'OG001'}, {'value': '14.1', 'groupId': 'OG002'}, {'value': '18.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Kaplan-Meier', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.0', 'ciLowerLimit': '22.3', 'ciUpperLimit': '30.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.0', 'estimateComment': 'Kaplan-Meier Event Rate Greenwood Standard Error', 'groupDescription': 'TAVR with the Medtronic CoreValve System meets the Performance Goal in the 12 month rate of all-cause mortality or major stroke H0: = πMCS TAVI ≥ 43.0% HA: = πMCS TAVI \\< 43.0% In the above expressions πMCS TAVI denotes the rate of all-cause mortality or major stroke during a fixed follow-up of 1 year.', 'statisticalMethod': 'z-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001'], 'paramType': 'Kaplan-Meier', 'ciNumSides': 'TWO_SIDED', 'paramValue': '39.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.0', 'estimateComment': 'Kaplan-Meier Event Rate Greenwood Standard Error', 'groupDescription': 'No performance goal created, only descriptive statistics are provided.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'z-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'The 12 month all-cause mortality estimated rate was 20% for each group with a noninferiority margin of 7.5 percentage points. Assuming a 1:1 ratio in the treatment assignments, we estimated that a total of 355 patients were required in each group for the study to have power of 80% at a one-sided alpha level of 0.05. Accounting for a 10% loss to follow-up, we calculated that we would need to enroll 790 patients.'}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)', 'unitOfMeasure': 'percentage of participants, Kaplan-Meier', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with an attempted implant procedure.'}, {'type': 'SECONDARY', 'title': 'Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}, {'value': '359', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'title': '30 day', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '17.3', 'groupId': 'OG001'}, {'value': '7.7', 'groupId': 'OG002'}, {'value': '10.3', 'groupId': 'OG003'}]}]}, {'title': '6 month', 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000'}, {'value': '34.7', 'groupId': 'OG001'}, {'value': '15.4', 'groupId': 'OG002'}, {'value': '21.0', 'groupId': 'OG003'}]}]}, {'title': '1 year', 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000'}, {'value': '41.4', 'groupId': 'OG001'}, {'value': '20.5', 'groupId': 'OG002'}, {'value': '27.0', 'groupId': 'OG003'}]}]}, {'title': '2 Year', 'categories': [{'measurements': [{'value': '42.3', 'groupId': 'OG000'}, {'value': '51.0', 'groupId': 'OG001'}, {'value': '29.7', 'groupId': 'OG002'}, {'value': '38.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.1033', 'groupIds': ['OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Hierarchical test item #5, MACCE at 30 days or hospital discharge; whichever was longer. K-M rates TAVR 8.21%, SAVR 10.93%, Difference -2.73%, Standard Error 2.16%, and Upper 95% CI 1.5%.', 'groupDescription': 'Powered Secondary Hypothesis: TAVR with the Medtronic CoreValve System was superior to SAVR in binary rate of MACCE at 30 days or hospital discharge, whichever was longer:\n\nH0: πMCS TAVR = πSAVR HA: πMCS TAVR \\< πSAVR In the above expression πMCS TAVR and πSAVR denoted rates of MACCE at 30 days or hospital discharge, whichever was longer.\n\nAssumptions:\n\n1:1 treatment allocation ratio One-sided alpha=0.025 SAVR = 20.0% MCS TAVI = 12.1% Power = \\>80%', 'statisticalMethod': 'Kaplan-Meier Point Estimate', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Using Greenwood formula'}], 'paramType': 'NUMBER', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'MACCE is defined as a composite of:\n\n* All Cause Mortality\n* Myocardial infarction (MI)\n* All Stroke\n* Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)', 'unitOfMeasure': 'percentage of participants, Kaplan-Meier', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with an attempted implant procedure.'}, {'type': 'SECONDARY', 'title': 'The Occurrence of Individual MACCE Components', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}, {'value': '359', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'title': '30 day All Cause Mortality', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000'}, {'value': '11.3', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}, {'value': '4.5', 'groupId': 'OG003'}]}]}, {'title': '30 day MI', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}]}]}, {'title': '30 day Stroke', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '8.8', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}, {'value': '6.2', 'groupId': 'OG003'}]}]}, {'title': '30 day Reintervention', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': '6 month All Cause Mortality', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '28.7', 'groupId': 'OG001'}, {'value': '9.0', 'groupId': 'OG002'}, {'value': '14.0', 'groupId': 'OG003'}]}]}, {'title': '6 month MI', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '1.1', 'groupId': 'OG003'}]}]}, {'title': '6 month Stroke', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '12.0', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}, {'value': '9.9', 'groupId': 'OG003'}]}]}, {'title': '6 month Reintervention', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': '1 year All Cause Mortality', 'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000'}, {'value': '36.0', 'groupId': 'OG001'}, {'value': '14.1', 'groupId': 'OG002'}, {'value': '18.9', 'groupId': 'OG003'}]}]}, {'title': '1 year MI', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}, {'value': '1.5', 'groupId': 'OG003'}]}]}, {'title': '1 year Stroke', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}, {'value': '13.0', 'groupId': 'OG001'}, {'value': '8.7', 'groupId': 'OG002'}, {'value': '12.5', 'groupId': 'OG003'}]}]}, {'title': '1 year Reintervention', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '2.2', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': '2 year All Cause Mortality', 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000'}, {'value': '44.9', 'groupId': 'OG001'}, {'value': '22.2', 'groupId': 'OG002'}, {'value': '28.6', 'groupId': 'OG003'}]}]}, {'title': '2 year MI', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}, {'value': '2.3', 'groupId': 'OG003'}]}]}, {'title': '2 year Stroke', 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '10.9', 'groupId': 'OG002'}, {'value': '16.6', 'groupId': 'OG003'}]}]}, {'title': '2 year Reintervention', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '2.5', 'groupId': 'OG002'}, {'value': '0.4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'Individual MACCE Components Include:\n\n* All Cause Mortality\n* MI\n* All stroke\n* Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)', 'unitOfMeasure': 'percentage of participants, Kaplan-Meier', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with an attempted implant procedure.'}, {'type': 'SECONDARY', 'title': 'Major Adverse Events (MAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}, {'value': '359', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'title': '30 day', 'categories': [{'measurements': [{'value': '54.2', 'groupId': 'OG000'}, {'value': '69.3', 'groupId': 'OG001'}, {'value': '52.4', 'groupId': 'OG002'}, {'value': '50.2', 'groupId': 'OG003'}]}]}, {'title': '6 month', 'categories': [{'measurements': [{'value': '60.5', 'groupId': 'OG000'}, {'value': '76.0', 'groupId': 'OG001'}, {'value': '58.6', 'groupId': 'OG002'}, {'value': '76.4', 'groupId': 'OG003'}]}]}, {'title': '1 year', 'categories': [{'measurements': [{'value': '63.4', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}, {'value': '60.1', 'groupId': 'OG002'}, {'value': '59.8', 'groupId': 'OG003'}]}]}, {'title': '2 year', 'categories': [{'measurements': [{'value': '71.3', 'groupId': 'OG000'}, {'value': '84.0', 'groupId': 'OG001'}, {'value': '66.4', 'groupId': 'OG002'}, {'value': '66.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'MAEs Include:\n\n* MACCE\n* Acute Kidney Injury\n* Cardiac Tamponade\n* Prosthetic Valve Dysfunction\n* Cardiogenic Shock\n* Valve Endocarditis\n* Life-Threatening, Disabling or Major Bleeding\n* Major Vascular Complication\n* Cardiac Perforation\n* Device Migration/Valve Embolism', 'unitOfMeasure': 'percentage of participants, Kaplan-Meier', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with an attempted implant procedure.'}, {'type': 'SECONDARY', 'title': 'Conduction Disturbance Requiring Permanent Pacemaker Implantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}, {'value': '359', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'title': '30 day', 'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000'}, {'value': '16.4', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}, {'value': '7.1', 'groupId': 'OG003'}]}]}, {'title': '6 month', 'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000'}, {'value': '20.5', 'groupId': 'OG001'}, {'value': '21.9', 'groupId': 'OG002'}, {'value': '9.9', 'groupId': 'OG003'}]}]}, {'title': '1 year', 'categories': [{'measurements': [{'value': '26.4', 'groupId': 'OG000'}, {'value': '21.5', 'groupId': 'OG001'}, {'value': '22.5', 'groupId': 'OG002'}, {'value': '11.6', 'groupId': 'OG003'}]}]}, {'title': '2 year', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '22.6', 'groupId': 'OG001'}, {'value': '25.8', 'groupId': 'OG002'}, {'value': '12.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'unitOfMeasure': 'percentage of participants, Kaplan-Meier', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with an attempted implant procedure.'}, {'type': 'SECONDARY', 'title': 'Change in NYHA Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}, {'value': '359', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'title': '30 day', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '0.9', 'groupId': 'OG003'}]}]}, {'title': '6 month', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': '1 year', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-1.5', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': '2 year', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '-1.5', 'spread': '0.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.6', 'pValueComment': 'Hierarchical test item #3, change from baseline to 1 year.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.9', 'groupDescription': 'Change in NYHA classification from baseline to 1 year from secondary objective #5. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Hierarchical test item #3, change from baseline to 1 year.', 'groupDescription': 'Change in NYHA classification from baseline to 1 year: TAVR vs. SAVR from secondary objective #5. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:\n\nH0: µ MCS TAVR ≤ µ SAVR -0.375 HA: µ MCS TAVR \\> µ SAVR -0.375 In the above expression µ MCS TAVR and µ SAVR denoted the mean number of classification improvements in NYHA from baseline to 1 year.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority margin= 0.375. For subjects with NYHA categories at both baseline and 1 year visit, the NYHA classification improvements were calculated as NYHAbaseline - NYHA1year.'}], 'paramType': 'MEAN', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement.\n\nNew York Heart Association (NYHA) Classification:\n\nClass I: Subjects with cardiac disease but without resulting limitations of physical activity.\n\nClass I: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.', 'unitOfMeasure': 'average classification level change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with an attempted implant procedure.'}, {'type': 'SECONDARY', 'title': 'Change in Distance Walked During 6-Minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}, {'value': '359', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'title': '30 day', 'categories': [{'measurements': [{'value': '19.6', 'spread': '109.1', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '110.0', 'groupId': 'OG001'}, {'value': '25.8', 'spread': '105.5', 'groupId': 'OG002'}, {'value': '-6.9', 'spread': '89.8', 'groupId': 'OG003'}]}]}, {'title': '1 year', 'categories': [{'measurements': [{'value': '13.9', 'spread': '140.4', 'groupId': 'OG000'}, {'value': '22.2', 'spread': '136.2', 'groupId': 'OG001'}, {'value': '27.0', 'spread': '114.3', 'groupId': 'OG002'}, {'value': '24.0', 'spread': '111.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 day, 1 year', 'description': 'Change in distance walked during 6MWT from baseline', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with an attempted implant procedure.'}, {'type': 'SECONDARY', 'title': 'Ratio of Days Alive Out of Hospital Versus Total Days Alive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}, {'value': '359', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.86', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '0.92', 'spread': '0.20', 'groupId': 'OG002'}, {'value': '0.89', 'spread': '0.23', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'ratio of days alive and out of hospital', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with an attempted implant procedure.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QoL) Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}, {'value': '359', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'title': '30 day KCCQ- Overall', 'categories': [{'measurements': [{'value': '24.2', 'spread': '28.9', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '33.5', 'groupId': 'OG001'}, {'value': '19.0', 'spread': '29.4', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '28.1', 'groupId': 'OG003'}]}]}, {'title': '30 day KCCQ- Clinical', 'categories': [{'measurements': [{'value': '20.2', 'spread': '28.0', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '32.0', 'groupId': 'OG001'}, {'value': '14.7', 'spread': '28.6', 'groupId': 'OG002'}, {'value': '2.7', 'spread': '27.1', 'groupId': 'OG003'}]}]}, {'title': '30 day SF-12-Physical', 'categories': [{'measurements': [{'value': '5.9', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '10.4', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '10.2', 'groupId': 'OG002'}, {'value': '-0.0', 'spread': '10.1', 'groupId': 'OG003'}]}]}, {'title': '30 day SF-12-Mental', 'categories': [{'measurements': [{'value': '3.7', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '16.2', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '13.1', 'groupId': 'OG002'}, {'value': '-2.5', 'spread': '13.4', 'groupId': 'OG003'}]}]}, {'title': '30 day EQ-5D', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.24', 'groupId': 'OG002'}, {'value': '-0.07', 'spread': '0.26', 'groupId': 'OG003'}]}]}, {'title': '6 month KCCQ-Overall', 'categories': [{'measurements': [{'value': '27.4', 'spread': '27.0', 'groupId': 'OG000'}, {'value': '23.1', 'spread': '28.3', 'groupId': 'OG001'}, {'value': '24.8', 'spread': '26.9', 'groupId': 'OG002'}, {'value': '22.9', 'spread': '26.4', 'groupId': 'OG003'}]}]}, {'title': '6 month KCCQ- Clinical', 'categories': [{'measurements': [{'value': '22.2', 'spread': '26.1', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '26.6', 'groupId': 'OG001'}, {'value': '18.6', 'spread': '25.7', 'groupId': 'OG002'}, {'value': '17.7', 'spread': '25.7', 'groupId': 'OG003'}]}]}, {'title': '6 month SF-12-Physical', 'categories': [{'measurements': [{'value': '5.2', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '11.0', 'groupId': 'OG002'}, {'value': '6.2', 'spread': '9.9', 'groupId': 'OG003'}]}]}, {'title': '6 month SF-12-Mental', 'categories': [{'measurements': [{'value': '4.6', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '13.8', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '11.8', 'groupId': 'OG002'}, {'value': '2.6', 'spread': '13.1', 'groupId': 'OG003'}]}]}, {'title': '6 month EQ-5D', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '0.22', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.17', 'groupId': 'OG003'}]}]}, {'title': '1 year KCCQ-Overall', 'categories': [{'measurements': [{'value': '27.9', 'spread': '27.1', 'groupId': 'OG000'}, {'value': '21.9', 'spread': '26.8', 'groupId': 'OG001'}, {'value': '23.2', 'spread': '25.4', 'groupId': 'OG002'}, {'value': '21.8', 'spread': '26.5', 'groupId': 'OG003'}]}]}, {'title': '1 year KCCQ- Clinical', 'categories': [{'measurements': [{'value': '20.8', 'spread': '26.8', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '24.9', 'groupId': 'OG001'}, {'value': '16.7', 'spread': '25.5', 'groupId': 'OG002'}, {'value': '15.2', 'spread': '26.0', 'groupId': 'OG003'}]}]}, {'title': '1 year SF-12-Physical', 'categories': [{'measurements': [{'value': '5.5', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '10.0', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '11.5', 'groupId': 'OG002'}, {'value': '5.3', 'spread': '10.3', 'groupId': 'OG003'}]}]}, {'title': '1 year SF-12-Mental', 'categories': [{'measurements': [{'value': '5.2', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '11.8', 'groupId': 'OG002'}, {'value': '3.2', 'spread': '12.1', 'groupId': 'OG003'}]}]}, {'title': '1 year EQ-5D', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.19', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.19', 'groupId': 'OG003'}]}]}, {'title': '2 year KCCQ - Overall', 'categories': [{'measurements': [{'value': '25.2', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '29.5', 'groupId': 'OG001'}, {'value': '22.2', 'spread': '26.5', 'groupId': 'OG002'}, {'value': '18.7', 'spread': '25.6', 'groupId': 'OG003'}]}]}, {'title': '2 year KCCQ - Clinical', 'categories': [{'measurements': [{'value': '18.8', 'spread': '26.1', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '26.9', 'groupId': 'OG001'}, {'value': '14.6', 'spread': '26.0', 'groupId': 'OG002'}, {'value': '12.6', 'spread': '25.8', 'groupId': 'OG003'}]}]}, {'title': '2 year SF-12 - Physical', 'categories': [{'measurements': [{'value': '4.0', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '12.1', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '10.2', 'groupId': 'OG003'}]}]}, {'title': '2 year SF-12 - Mental', 'categories': [{'measurements': [{'value': '3.8', 'spread': '15.3', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '14.8', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '13.0', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '13.0', 'groupId': 'OG003'}]}]}, {'title': '2 year EQ-5D', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.24', 'groupId': 'OG002'}, {'value': '-0.01', 'spread': '0.21', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Hierarchical test item #4', 'groupDescription': 'Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 1 year from secondary objective #8. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0063', 'groupIds': ['OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Hierarchical test item #4', 'groupDescription': 'Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 1 year: TAVR vs. SAVR from secondary objective #8. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:\n\nH0: µ MCS TAVR ≤ µ SAVR -5 HA: µ MCS TAVR \\> µ SAVR -5 In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in the KCCQ score from baseline to 1 year.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority margin 5'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Hierarchical test item #6. Item #5 failed, therefore, item #6 also fails. Nominal p- value provided.', 'groupDescription': 'Change in SF-12 Physical Summary Scale from baseline to 30 days: TAVR vs. SAVR from secondary objective #8. The two-sided two-sample t-test was used to test at a level 0.05 the hypotheses:\n\nH0: µ MCS TAVR = µ SAVR HA: µ MCS TAVR ≠ µ SAVR In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in the SF-12 Physical Summary Scale from baseline to 30 days.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'QoL summary score change from baseline using the following measures:\n\n* Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.\n* 12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.\n* European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with an attempted implant procedure.'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Valve Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '390', 'groupId': 'OG002'}, {'value': '354', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'title': '30 day EOA', 'categories': [{'measurements': [{'value': '1.86', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '1.82', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '1.94', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '1.60', 'spread': '0.51', 'groupId': 'OG003'}]}]}, {'title': '6 month EOA', 'categories': [{'measurements': [{'value': '1.88', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '1.85', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '1.91', 'spread': '0.53', 'groupId': 'OG002'}, {'value': '1.56', 'spread': '0.49', 'groupId': 'OG003'}]}]}, {'title': '1 year EOA', 'categories': [{'measurements': [{'value': '1.88', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '1.85', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '1.91', 'spread': '0.52', 'groupId': 'OG002'}, {'value': '1.57', 'spread': '0.49', 'groupId': 'OG003'}]}]}, {'title': '2 year EOA', 'categories': [{'measurements': [{'value': '1.86', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '1.83', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '1.87', 'spread': '0.48', 'groupId': 'OG002'}, {'value': '1.51', 'spread': '0.43', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Hierarchical test item #2', 'groupDescription': 'EOA:\n\nChange in effective orifice area from Baseline to 1 year from secondary objective #9. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Hierarchical test item #2', 'groupDescription': 'EOA:\n\nChange in effective orifice area from Baseline to 1 year: TAVR vs.SAVR from secondary objective #9. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:\n\nH0: µ MCS TAVR ≤ µ SAVR -0.375 HA: µ MCS TAVR \\> µ SAVR -0.375 In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in effective orifice area from Baseline to 1 year measured in cm2.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority margin 0.375'}], 'paramType': 'MEAN', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'Using the following measures:\n\n\\- Effective Orifice Area (EOA)', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with a valve implanted.'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Valve Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '390', 'groupId': 'OG002'}, {'value': '354', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'title': '30 day Mean Gradient', 'categories': [{'measurements': [{'value': '8.68', 'spread': '4.16', 'groupId': 'OG000'}, {'value': '9.74', 'spread': '5.82', 'groupId': 'OG001'}, {'value': '8.88', 'spread': '3.86', 'groupId': 'OG002'}, {'value': '11.72', 'spread': '5.70', 'groupId': 'OG003'}]}]}, {'title': '6 month Mean Gradient', 'categories': [{'measurements': [{'value': '9.10', 'spread': '3.89', 'groupId': 'OG000'}, {'value': '9.42', 'spread': '5.60', 'groupId': 'OG001'}, {'value': '9.08', 'spread': '4.08', 'groupId': 'OG002'}, {'value': '12.12', 'spread': '6.31', 'groupId': 'OG003'}]}]}, {'title': '1 year Mean Gradient', 'categories': [{'measurements': [{'value': '8.86', 'spread': '4.09', 'groupId': 'OG000'}, {'value': '9.46', 'spread': '5.65', 'groupId': 'OG001'}, {'value': '9.09', 'spread': '3.49', 'groupId': 'OG002'}, {'value': '12.44', 'spread': '7.36', 'groupId': 'OG003'}]}]}, {'title': '2 year Mean Gradient', 'categories': [{'measurements': [{'value': '8.70', 'spread': '4.22', 'groupId': 'OG000'}, {'value': '9.24', 'spread': '5.35', 'groupId': 'OG001'}, {'value': '8.47', 'spread': '3.76', 'groupId': 'OG002'}, {'value': '12.05', 'spread': '6.32', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Hierarchical test item #1', 'groupDescription': 'Transvalvular Mean Gradient:\n\nChange in transvalvular mean gradient from baseline to 1 year from secondary objective #9. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Hierarchical test item #1', 'groupDescription': 'Transvalvular Mean Gradient:\n\nChange in transvalvular mean gradient from baseline to 1 year: TAVR vs.SAVR from secondary objective #9. The one-sided two-sample t-test was used to test non-inferiority at a level of 0.05 the hypotheses: H0: μ MCS TAVR ≤ μ SAVR -15 HA: μ MCS TAVR \\> μ SAVR -15 In the above expression μ MCS TAVR and μ SAVR denoted the mean improvements in mean gradient from Baseline to 1 year measured in mmHg.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority margin 15'}], 'paramType': 'MEAN', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'Using the following measures:\n\n\\- Transvalvular Mean Gradient', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with a valve implanted.'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Assessment of Valve Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '390', 'groupId': 'OG002'}, {'value': '354', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'title': '30 day Total Aortic Regurgitation- None', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '19.0', 'groupId': 'OG001'}, {'value': '12.2', 'groupId': 'OG002'}, {'value': '65.0', 'groupId': 'OG003'}]}]}, {'title': '30 day Total Aortic Regurgitation- Trivial', 'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000'}, {'value': '33.9', 'groupId': 'OG001'}, {'value': '41.4', 'groupId': 'OG002'}, {'value': '23.0', 'groupId': 'OG003'}]}]}, {'title': '30 day Total Aortic Regurgitation- Mild', 'categories': [{'measurements': [{'value': '43.0', 'groupId': 'OG000'}, {'value': '34.7', 'groupId': 'OG001'}, {'value': '36.4', 'groupId': 'OG002'}, {'value': '10.7', 'groupId': 'OG003'}]}]}, {'title': '30 day Total Aortic Regurgitation- Moderate', 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '8.1', 'groupId': 'OG002'}, {'value': '1.3', 'groupId': 'OG003'}]}]}, {'title': '30 day Total Aortic Regurgitation- Severe', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': '6 month Total Aortic Regurgitation- None', 'categories': [{'measurements': [{'value': '19.9', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '21.6', 'groupId': 'OG002'}, {'value': '60.6', 'groupId': 'OG003'}]}]}, {'title': '6 month Total Aortic Regurgitation- Trivial', 'categories': [{'measurements': [{'value': '33.5', 'groupId': 'OG000'}, {'value': '27.1', 'groupId': 'OG001'}, {'value': '37.2', 'groupId': 'OG002'}, {'value': '28.0', 'groupId': 'OG003'}]}]}, {'title': '6 month Total Aortic Regurgitation- Mild', 'categories': [{'measurements': [{'value': '36.5', 'groupId': 'OG000'}, {'value': '35.4', 'groupId': 'OG001'}, {'value': '29.7', 'groupId': 'OG002'}, {'value': '9.8', 'groupId': 'OG003'}]}]}, {'title': '6 month Total Aortic Regurgitation- Moderate', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}, {'value': '1.6', 'groupId': 'OG003'}]}]}, {'title': '6 month Total Aortic Regurgitation- Severe', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': '1 year Total Aortic Regurgitation- None', 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000'}, {'value': '39.0', 'groupId': 'OG001'}, {'value': '28.3', 'groupId': 'OG002'}, {'value': '68.1', 'groupId': 'OG003'}]}]}, {'title': '1 year Total Aortic Regurgitation- Trivial', 'categories': [{'measurements': [{'value': '40.6', 'groupId': 'OG000'}, {'value': '36.6', 'groupId': 'OG001'}, {'value': '35.7', 'groupId': 'OG002'}, {'value': '21.7', 'groupId': 'OG003'}]}]}, {'title': '1 year Total Aortic Regurgitation- Mild', 'categories': [{'measurements': [{'value': '31.5', 'groupId': 'OG000'}, {'value': '20.7', 'groupId': 'OG001'}, {'value': '29.0', 'groupId': 'OG002'}, {'value': '8.8', 'groupId': 'OG003'}]}]}, {'title': '1 year Total Aortic Regurgitation- Moderate', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}, {'value': '6.7', 'groupId': 'OG002'}, {'value': '0.9', 'groupId': 'OG003'}]}]}, {'title': '1 year Total Aortic Regurgitation- Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}, {'value': '0.4', 'groupId': 'OG003'}]}]}, {'title': '2 year Total Aortic Regurgitation - None', 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000'}, {'value': '35.3', 'groupId': 'OG001'}, {'value': '32.8', 'groupId': 'OG002'}, {'value': '58.5', 'groupId': 'OG003'}]}]}, {'title': '2 year Total Aortic Regurgitation - Trivial', 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000'}, {'value': '36.8', 'groupId': 'OG001'}, {'value': '27.0', 'groupId': 'OG002'}, {'value': '27.3', 'groupId': 'OG003'}]}]}, {'title': '2 year Total Aortic Regurgitation - Mild', 'categories': [{'measurements': [{'value': '36.1', 'groupId': 'OG000'}, {'value': '23.5', 'groupId': 'OG001'}, {'value': '32.0', 'groupId': 'OG002'}, {'value': '13.1', 'groupId': 'OG003'}]}]}, {'title': '2 year Total Aortic Regurgitation - Moderate', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}, {'value': '6.6', 'groupId': 'OG002'}, {'value': '1.1', 'groupId': 'OG003'}]}]}, {'title': '2 year Total Aortic Regurgitation - Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'Using the following measure:\n\n\\- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with a valve implanted.'}, {'type': 'SECONDARY', 'title': 'Aortic Valve Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}, {'value': '359', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'title': '30 day', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '8.7', 'groupId': 'OG001'}, {'value': '3.9', 'groupId': 'OG002'}, {'value': '5.2', 'groupId': 'OG003'}]}]}, {'title': '6 month', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '18.3', 'groupId': 'OG001'}, {'value': '13.4', 'groupId': 'OG002'}, {'value': '9.0', 'groupId': 'OG003'}]}]}, {'title': '1 year', 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000'}, {'value': '21.2', 'groupId': 'OG001'}, {'value': '16.5', 'groupId': 'OG002'}, {'value': '14.0', 'groupId': 'OG003'}]}]}, {'title': '2 year', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000'}, {'value': '27.2', 'groupId': 'OG001'}, {'value': '24.2', 'groupId': 'OG002'}, {'value': '18.2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'unitOfMeasure': 'percentage of participants, Kaplan-Meier', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with an attempted implant procedure'}, {'type': 'SECONDARY', 'title': 'Cardiovascular Deaths and Valve Related Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}, {'value': '359', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'title': '30 day Cardiovascular Deaths', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000'}, {'value': '11.3', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}, {'value': '4.5', 'groupId': 'OG003'}]}]}, {'title': '30 Day Valve Related Deaths', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}, {'value': '2.3', 'groupId': 'OG002'}, {'value': '0.6', 'groupId': 'OG003'}]}]}, {'title': '6 month Cardiovascular Deaths', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000'}, {'value': '23.6', 'groupId': 'OG001'}, {'value': '7.4', 'groupId': 'OG002'}, {'value': '10.5', 'groupId': 'OG003'}]}]}, {'title': '6 month Valve Related Deaths', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}, {'value': '1.8', 'groupId': 'OG003'}]}]}, {'title': '1 year Cardiovascular Deaths', 'categories': [{'measurements': [{'value': '18.3', 'groupId': 'OG000'}, {'value': '28.7', 'groupId': 'OG001'}, {'value': '10.6', 'groupId': 'OG002'}, {'value': '12.9', 'groupId': 'OG003'}]}]}, {'title': '1 year Valve Related Deaths', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '5.4', 'groupId': 'OG001'}, {'value': '5.6', 'groupId': 'OG002'}, {'value': '2.2', 'groupId': 'OG003'}]}]}, {'title': '2 year Cardiovascular Deaths', 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}, {'value': '35.1', 'groupId': 'OG001'}, {'value': '15.4', 'groupId': 'OG002'}, {'value': '19.4', 'groupId': 'OG003'}]}]}, {'title': '2 year Valve Related Deaths', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '7.5', 'groupId': 'OG001'}, {'value': '6.8', 'groupId': 'OG002'}, {'value': '4.2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'unitOfMeasure': 'percentage of participants, Kaplan-Meier', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with an attempted implant procedure.'}, {'type': 'SECONDARY', 'title': 'Strokes and Transient Ischemic Attacks (TIAs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}, {'value': '359', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'title': '30 day', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}, {'value': '5.7', 'groupId': 'OG002'}, {'value': '6.5', 'groupId': 'OG003'}]}]}, {'title': '6 month', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '8.4', 'groupId': 'OG002'}, {'value': '10.8', 'groupId': 'OG003'}]}]}, {'title': '1 year', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '15.2', 'groupId': 'OG001'}, {'value': '10.3', 'groupId': 'OG002'}, {'value': '14.1', 'groupId': 'OG003'}]}]}, {'title': '2 year', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}, {'value': '19.5', 'groupId': 'OG001'}, {'value': '13.2', 'groupId': 'OG002'}, {'value': '17.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'Strokes (of any severity) and TIAs', 'unitOfMeasure': 'percentage of participants, Kaplan-Meier', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with an attempted implant procedure.'}, {'type': 'SECONDARY', 'title': 'Index Procedure Related MAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}, {'value': '359', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'groupId': 'OG000'}, {'value': '68.9', 'groupId': 'OG001'}, {'value': '52.6', 'groupId': 'OG002'}, {'value': '49.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Procedure', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with an attempted implant procedure.'}, {'type': 'SECONDARY', 'title': 'Length of Index Procedure Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}, {'value': '359', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '8.0', 'spread': '6.8', 'groupId': 'OG002'}, {'value': '12.5', 'spread': '10.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Number of days from admission to discharge', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with an attempted implant procedure.'}, {'type': 'SECONDARY', 'title': 'Device Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '468', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '378', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000'}, {'value': '88.7', 'groupId': 'OG001'}, {'value': '86.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Number of days from admission to discharge', 'description': 'Medtronic CoreValve® System subjects only.\n\nDefined as:\n\n* Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system,\n* Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function),\n* Intended performance of the prosthetic valve (aortic valve area \\> 1.2 cm2 for 26, 29 and 31mm valves, ≥ 0.9 cm2 for 23mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient \\< 20 mmHg or peak velocity \\< 3 m/sec, without moderate or severe prosthetic valve aortic regurgitation)\n* Only one valve implanted in the proper anatomical location', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for device success.'}, {'type': 'SECONDARY', 'title': 'Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '384', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000'}, {'value': '77.5', 'groupId': 'OG001'}, {'value': '81.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Number of days from admission to discharge', 'description': 'Medtronic CoreValve® System subjects only.\n\nDefined as device success and absence of in-hospital MACCE.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for procedural success.'}, {'type': 'SECONDARY', 'title': 'Prosthetic Valve Dysfunction (PVD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '390', 'groupId': 'OG002'}, {'value': '354', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'OG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'OG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'OG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'classes': [{'title': '30 day Aortic Stenosis', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}, {'value': '6.1', 'groupId': 'OG001'}, {'value': '3.1', 'groupId': 'OG002'}, {'value': '4.8', 'groupId': 'OG003'}]}]}, {'title': '30 day Aortic Regurgitation', 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000'}, {'value': '16.9', 'groupId': 'OG001'}, {'value': '13.6', 'groupId': 'OG002'}, {'value': '1.7', 'groupId': 'OG003'}]}]}, {'title': '6 month Aortic Stenosis', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '6.1', 'groupId': 'OG001'}, {'value': '3.8', 'groupId': 'OG002'}, {'value': '6.5', 'groupId': 'OG003'}]}]}, {'title': '6 month Aortic Regurgitation', 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}, {'value': '18.2', 'groupId': 'OG001'}, {'value': '17.2', 'groupId': 'OG002'}, {'value': '2.3', 'groupId': 'OG003'}]}]}, {'title': '1 year Aortic Stenosis', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '6.1', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}, {'value': '8.2', 'groupId': 'OG003'}]}]}, {'title': '1 year Aortic Regurgitation', 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}, {'value': '2.8', 'groupId': 'OG003'}]}]}, {'title': '2 year Aortic Stenosis', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}, {'value': '9.3', 'groupId': 'OG003'}]}]}, {'title': '2 year Aortic Regurgitation', 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}, {'value': '19.7', 'groupId': 'OG002'}, {'value': '2.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'PVD was defined according to VARC I using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total AR reported as moderate or severe was considered PVD. AS was defined as significant stenosis and considered PVD if one of the following was met:\n\n* Peak velocity \\>4 m/s\n* Mean gradient \\>35 mmHg\n* EOA \\< 0.8 cm2\n* TVIV1 / TVIV2 \\< 0.25', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant Population= Consisted of all subjects with a valve implanted.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'FG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'FG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'FG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '500'}, {'groupId': 'FG001', 'numSubjects': '156'}, {'groupId': 'FG002', 'numSubjects': '395'}, {'groupId': 'FG003', 'numSubjects': '402'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '289'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '295'}, {'groupId': 'FG003', 'numSubjects': '237'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '100'}, {'groupId': 'FG003', 'numSubjects': '165'}]}]}], 'recruitmentDetails': 'Between Feb 17, 2011 and Aug 23, 2013, 656 subjects were enrolled into the CoreValve US Pivotal Trial Extreme Risk study at 41 of the 43 activated centers in the United States. Between February 2, 2011 and July 23, 2013, 797 subjects were enrolled into the CoreValve US Pivotal Trial High Risk study at 45 centers in the United States.', 'preAssignmentDetails': 'The first 3 successfully enrolled and implanted iliofemoral subjects at each implanting site, inclusive of both the High Risk Surgical and Extreme Risk patient populations were considered roll-in subjects, and were automatically assigned to undergo Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '391', 'groupId': 'BG002'}, {'value': '359', 'groupId': 'BG003'}, {'value': '1389', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access'}, {'id': 'BG001', 'title': 'Extreme Risk: TAVI Non-Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access'}, {'id': 'BG002', 'title': 'High Risk: TAVI', 'description': 'High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)'}, {'id': 'BG003', 'title': 'High Risk: SAVR', 'description': 'High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '83.2', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '81.3', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '83.2', 'spread': '7.1', 'groupId': 'BG002'}, {'value': '83.3', 'spread': '6.4', 'groupId': 'BG003'}, {'value': '83.0', 'spread': '7.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Participant Population= Consisted of all subjects with an attempted implant procedure.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '255', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}, {'value': '692', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '234', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}, {'value': '188', 'groupId': 'BG003'}, {'value': '697', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participant Population= Consisted of all subjects with an attempted implant procedure.', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '468', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '387', 'groupId': 'BG002'}, {'value': '343', 'groupId': 'BG003'}, {'value': '1341', 'groupId': 'BG004'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Participant Population= Consisted of all subjects with an attempted implant procedure.', 'unitOfMeasure': 'participants'}, {'title': 'Body Surface Area', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '1.8', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '1.8', 'spread': '0.2', 'groupId': 'BG002'}, {'value': '1.9', 'spread': '0.2', 'groupId': 'BG003'}, {'value': '1.8', 'spread': '0.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Participant Population= Consisted of all subjects with an attempted implant procedure.', 'unitOfMeasure': 'm^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'NYHA Classification', 'classes': [{'title': 'NYHA I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'NYHA II', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '156', 'groupId': 'BG004'}]}]}, {'title': 'NYHA III', 'categories': [{'measurements': [{'value': '313', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}, {'value': '250', 'groupId': 'BG003'}, {'value': '916', 'groupId': 'BG004'}]}]}, {'title': 'NYHA IV', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '317', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'New York Heart Association (NYHA) Classification:\n\nClass I: Subjects with cardiac disease but without resulting limitations of physical activity.\n\nClass I: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.', 'unitOfMeasure': 'participants'}, {'title': 'Society of Thoracic Surgeons (STS) Risk Score', 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '10.7', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '7.3', 'spread': '3.0', 'groupId': 'BG002'}, {'value': '7.5', 'spread': '3.3', 'groupId': 'BG003'}, {'value': '8.8', 'spread': '4.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The Society of Thoracic Surgeons (STS) risk model predicts the risk of operative mortality and morbidity after adult cardiac surgery on the basis of patient demographic and clinical variables. After information has been entered on a given case, the online STS risk calculator provides a risk percentage for each of the outcomes. The risk percentage estimates the chance of a specific outcome for a patient with the indicated risk factors. A higher score indicates a higher risk. A lower score indicates a lower risk.', 'unitOfMeasure': '% risk of mortality or morbidity', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE)', 'classes': [{'categories': [{'measurements': [{'value': '22.6', 'spread': '17.1', 'groupId': 'BG000'}, {'value': '22.9', 'spread': '15.9', 'groupId': 'BG001'}, {'value': '17.7', 'spread': '13.0', 'groupId': 'BG002'}, {'value': '18.8', 'spread': '13.2', 'groupId': 'BG003'}, {'value': '20.3', 'spread': '15.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The European System for Cardiac Operative Risk Evaluation (EuroSCORE) is a method of calculating predicted operative mortality for patients undergoing cardiac surgery. If a risk factor is present, a weight/number is assigned. The weights are added to give an approximate percent of predicted mortality. A higher score indicates a higher risk. A lower score indicates a lower risk.', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Participant Population= As Treated (AT) cohort. The AT cohort consisted of all Intent to Treat (ITT) subjects with an attempted implant procedure.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1453}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-21', 'studyFirstSubmitDate': '2010-11-10', 'resultsFirstSubmitDate': '2015-03-06', 'studyFirstSubmitQcDate': '2010-11-12', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-05-20', 'studyFirstPostDateStruct': {'date': '2010-11-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality', 'timeFrame': '1 year', 'description': 'All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)'}], 'secondaryOutcomes': [{'measure': 'Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'MACCE is defined as a composite of:\n\n* All Cause Mortality\n* Myocardial infarction (MI)\n* All Stroke\n* Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)'}, {'measure': 'The Occurrence of Individual MACCE Components', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'Individual MACCE Components Include:\n\n* All Cause Mortality\n* MI\n* All stroke\n* Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)'}, {'measure': 'Major Adverse Events (MAEs)', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'MAEs Include:\n\n* MACCE\n* Acute Kidney Injury\n* Cardiac Tamponade\n* Prosthetic Valve Dysfunction\n* Cardiogenic Shock\n* Valve Endocarditis\n* Life-Threatening, Disabling or Major Bleeding\n* Major Vascular Complication\n* Cardiac Perforation\n* Device Migration/Valve Embolism'}, {'measure': 'Conduction Disturbance Requiring Permanent Pacemaker Implantation', 'timeFrame': '30 day, 6 month, 1 year, 2 year'}, {'measure': 'Change in NYHA Class', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement.\n\nNew York Heart Association (NYHA) Classification:\n\nClass I: Subjects with cardiac disease but without resulting limitations of physical activity.\n\nClass I: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.'}, {'measure': 'Change in Distance Walked During 6-Minute Walk Test (6MWT)', 'timeFrame': '30 day, 1 year', 'description': 'Change in distance walked during 6MWT from baseline'}, {'measure': 'Ratio of Days Alive Out of Hospital Versus Total Days Alive', 'timeFrame': '1 year'}, {'measure': 'Quality of Life (QoL) Change', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'QoL summary score change from baseline using the following measures:\n\n* Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.\n* 12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.\n* European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.'}, {'measure': 'Echocardiographic Assessment of Valve Performance', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'Using the following measures:\n\n\\- Effective Orifice Area (EOA)'}, {'measure': 'Echocardiographic Assessment of Valve Performance', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'Using the following measures:\n\n\\- Transvalvular Mean Gradient'}, {'measure': 'Echocardiographic Assessment of Valve Performance', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'Using the following measure:\n\n\\- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)'}, {'measure': 'Aortic Valve Hospitalizations', 'timeFrame': '30 day, 6 month, 1 year, 2 year'}, {'measure': 'Cardiovascular Deaths and Valve Related Deaths', 'timeFrame': '30 day, 6 month, 1 year, 2 year'}, {'measure': 'Strokes and Transient Ischemic Attacks (TIAs)', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'Strokes (of any severity) and TIAs'}, {'measure': 'Index Procedure Related MAEs', 'timeFrame': 'Procedure'}, {'measure': 'Length of Index Procedure Hospital Stay', 'timeFrame': 'Number of days from admission to discharge'}, {'measure': 'Device Success', 'timeFrame': 'Number of days from admission to discharge', 'description': 'Medtronic CoreValve® System subjects only.\n\nDefined as:\n\n* Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system,\n* Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function),\n* Intended performance of the prosthetic valve (aortic valve area \\> 1.2 cm2 for 26, 29 and 31mm valves, ≥ 0.9 cm2 for 23mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient \\< 20 mmHg or peak velocity \\< 3 m/sec, without moderate or severe prosthetic valve aortic regurgitation)\n* Only one valve implanted in the proper anatomical location'}, {'measure': 'Procedural Success', 'timeFrame': 'Number of days from admission to discharge', 'description': 'Medtronic CoreValve® System subjects only.\n\nDefined as device success and absence of in-hospital MACCE.'}, {'measure': 'Prosthetic Valve Dysfunction (PVD)', 'timeFrame': '30 day, 6 month, 1 year, 2 year', 'description': 'PVD was defined according to VARC I using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total AR reported as moderate or severe was considered PVD. AS was defined as significant stenosis and considered PVD if one of the following was met:\n\n* Peak velocity \\>4 m/s\n* Mean gradient \\>35 mmHg\n* EOA \\< 0.8 cm2\n* TVIV1 / TVIV2 \\< 0.25'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Valvular Heart Disease', 'Critical Aortic Stenosis', 'Severe Aortic Stenosis', 'High Risk', 'Aortic Valve Replacement'], 'conditions': ['Severe Aortic Stenosis']}, 'referencesModule': {'references': [{'pmid': '36515976', 'type': 'DERIVED', 'citation': "O'Hair D, Yakubov SJ, Grubb KJ, Oh JK, Ito S, Deeb GM, Van Mieghem NM, Adams DH, Bajwa T, Kleiman NS, Chetcuti S, Sondergaard L, Gada H, Mumtaz M, Heiser J, Merhi WM, Petrossian G, Robinson N, Tang GHL, Rovin JD, Little SH, Jain R, Verdoliva S, Hanson T, Li S, Popma JJ, Reardon MJ. Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk. JAMA Cardiol. 2023 Feb 1;8(2):111-119. doi: 10.1001/jamacardio.2022.4627."}, {'pmid': '34581194', 'type': 'DERIVED', 'citation': 'Lanz J, Reardon MJ, Pilgrim T, Stortecky S, Deeb GM, Chetcuti S, Yakubov SJ, Gleason TG, Huang J, Windecker S. Incidence and Outcomes of Infective Endocarditis After Transcatheter or Surgical Aortic Valve Replacement. J Am Heart Assoc. 2021 Oct 5;10(19):e020368. doi: 10.1161/JAHA.120.020368. Epub 2021 Sep 28.'}, {'pmid': '34092091', 'type': 'DERIVED', 'citation': 'Arnold SV, Petrossian G, Reardon MJ, Kleiman NS, Yakubov SJ, Wang K, Hermiller J Jr, Harrison JK, Deeb GM, Huang J, Cohen DJ; US CoreValve Investigators. Five-Year Clinical and Quality of Life Outcomes From the CoreValve US Pivotal Extreme Risk Trial. Circ Cardiovasc Interv. 2021 Jun;14(6):e010258. doi: 10.1161/CIRCINTERVENTIONS.120.010258. Epub 2021 Jun 7.'}, {'pmid': '32997095', 'type': 'DERIVED', 'citation': 'Arnold SV, Chinnakondepalli KM, Magnuson EA, Reardon MJ, Deeb GM, Gleason T, Yakubov SJ, Cohen DJ; CoreValve US Pivotal Trial Investigators. Five-Year Health Status After Self-expanding Transcatheter or Surgical Aortic Valve Replacement in High-risk Patients With Severe Aortic Stenosis. JAMA Cardiol. 2021 Jan 1;6(1):97-101. doi: 10.1001/jamacardio.2020.4397.'}, {'pmid': '31902431', 'type': 'DERIVED', 'citation': 'Ito S, Nkomo VT, Orsinelli DA, Lin G, Cavalcante J, Popma JJ, Adams DH, Checuti SJ, Deeb GM, Boulware M, Huang J, Little SH, Cohen SA, Reardon MJ, Oh JK. Impact of Stroke Volume Index and Left Ventricular Ejection Fraction on Mortality After Aortic Valve Replacement. Mayo Clin Proc. 2020 Jan;95(1):69-76. doi: 10.1016/j.mayocp.2019.10.031.'}, {'pmid': '31665959', 'type': 'DERIVED', 'citation': "Lindman BR, Goel K, Bermejo J, Beckman J, O'Leary J, Barker CM, Kaiser C, Cavalcante JL, Elmariah S, Huang J, Hickey GL, Adams DH, Popma JJ, Reardon MJ. Lower Blood Pressure After Transcatheter or Surgical Aortic Valve Replacement is Associated with Increased Mortality. J Am Heart Assoc. 2019 Nov 5;8(21):e014020. doi: 10.1161/JAHA.119.014020. Epub 2019 Oct 31."}, {'pmid': '30341970', 'type': 'DERIVED', 'citation': "Pineda AM, Kevin Harrison J, Kleiman NS, Reardon MJ, Conte JV, O'Hair DP, Chetcuti SJ, Huang J, Yakubov SJ, Popma JJ, Beohar N. Clinical impact of baseline chronic kidney disease in patients undergoing transcatheter or surgical aortic valve replacement. Catheter Cardiovasc Interv. 2019 Mar 1;93(4):740-748. doi: 10.1002/ccd.27928. Epub 2018 Oct 20."}, {'pmid': '30249462', 'type': 'DERIVED', 'citation': 'Gleason TG, Reardon MJ, Popma JJ, Deeb GM, Yakubov SJ, Lee JS, Kleiman NS, Chetcuti S, Hermiller JB Jr, Heiser J, Merhi W, Zorn GL 3rd, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte JV, Mumtaz M, Oh JK, Huang J, Adams DH; CoreValve U.S. Pivotal High Risk Trial Clinical Investigators. 5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients. J Am Coll Cardiol. 2018 Dec 4;72(22):2687-2696. doi: 10.1016/j.jacc.2018.08.2146. Epub 2018 Sep 21.'}, {'pmid': '30172363', 'type': 'DERIVED', 'citation': 'Grayburn PA, Oh JK, Reardon MJ, Popma JJ, Deeb GM, Boulware M, Huang J, Stoler RC. Effect of Baseline Aortic Regurgitation on Mortality in Patients Treated With Transcatheter or Surgical Aortic Valve Replacement (from the CoreValve US Pivotal Trial). Am J Cardiol. 2018 Nov 1;122(9):1527-1535. doi: 10.1016/j.amjcard.2018.07.018. Epub 2018 Aug 3.'}, {'pmid': '29102579', 'type': 'DERIVED', 'citation': 'Crestanello JA, Popma JJ, Adams DH, Deeb GM, Mumtaz M, George B, Huang J, Reardon MJ. Long-Term Health Benefit of Transcatheter Aortic Valve Replacement in Patients With Chronic Lung Disease. JACC Cardiovasc Interv. 2017 Nov 27;10(22):2283-2293. doi: 10.1016/j.jcin.2017.07.025. Epub 2017 Nov 1.'}, {'pmid': '27601429', 'type': 'DERIVED', 'citation': 'Kleiman NS, Maini BJ, Reardon MJ, Conte J, Katz S, Rajagopal V, Kauten J, Hartman A, McKay R, Hagberg R, Huang J, Popma J; CoreValve Investigators. Neurological Events Following Transcatheter Aortic Valve Replacement and Their Predictors: A Report From the CoreValve Trials. Circ Cardiovasc Interv. 2016 Sep;9(9):e003551. doi: 10.1161/CIRCINTERVENTIONS.115.003551.'}, {'pmid': '27541162', 'type': 'DERIVED', 'citation': "Reardon MJ, Kleiman NS, Adams DH, Yakubov SJ, Coselli JS, Deeb GM, O'Hair D, Gleason TG, Lee JS, Hermiller JB Jr, Chetcuti S, Heiser J, Merhi W, Zorn GL 3rd, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Maini B, Mumtaz M, Conte JV, Resar JR, Aharonian V, Pfeffer T, Oh JK, Huang J, Popma JJ. Outcomes in the Randomized CoreValve US Pivotal High Risk Trial in Patients With a Society of Thoracic Surgeons Risk Score of 7% or Less. JAMA Cardiol. 2016 Nov 1;1(8):945-949. doi: 10.1001/jamacardio.2016.2257."}, {'pmid': '27491485', 'type': 'DERIVED', 'citation': 'Popma JJ, Reardon MJ, Yakubov SJ, Hermiller JB Jr, Harrison JK, Gleason TG, Conte JV, Deeb GM, Chetcuti S, Oh JK, Boulware MJ, Huang J, Adams DH; CoreValve US Clinical Investigators. Safety and Efficacy of Self-Expanding TAVR in Patients With Aortoventricular Angulation. JACC Cardiovasc Imaging. 2016 Aug;9(8):973-81. doi: 10.1016/j.jcmg.2016.06.002.'}, {'pmid': '27443429', 'type': 'DERIVED', 'citation': 'Hermiller JB Jr, Yakubov SJ, Reardon MJ, Deeb GM, Adams DH, Afilalo J, Huang J, Popma JJ; CoreValve United States Clinical Investigators. Predicting Early and Late Mortality After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2016 Jul 26;68(4):343-52. doi: 10.1016/j.jacc.2016.04.057.'}, {'pmid': '27369803', 'type': 'DERIVED', 'citation': 'Popma JJ, Gleason TG, Yakubov SJ, Harrison JK, Forrest JK, Maini B, Ruiz CE, Pinto DS, Costa M, Resar J, Conte J, Crestanello J, Chang Y, Oh JK, Reardon MJ, Adams DH. Relationship of Annular Sizing Using Multidetector Computed Tomographic Imaging and Clinical Outcomes After Self-Expanding CoreValve Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2016 Jul;9(7):e003282. doi: 10.1161/CIRCINTERVENTIONS.115.003282.'}, {'pmid': '27313280', 'type': 'DERIVED', 'citation': 'Little SH, Oh JK, Gillam L, Sengupta PP, Orsinelli DA, Cavalcante JL, Chang JD, Adams DH, Zorn GL 3rd, Pollak AW, Abdelmoneim SS, Reardon MJ, Qiao H, Popma JJ. Self-Expanding Transcatheter Aortic Valve Replacement Versus Surgical Valve Replacement in Patients at High Risk for Surgery: A Study of Echocardiographic Change and Risk Prediction. Circ Cardiovasc Interv. 2016 Jun;9(6):e003426. doi: 10.1161/CIRCINTERVENTIONS.115.003426.'}, {'pmid': '27296201', 'type': 'DERIVED', 'citation': 'Dauerman HL, Reardon MJ, Popma JJ, Little SH, Cavalcante JL, Adams DH, Kleiman NS, Oh JK. Early Recovery of Left Ventricular Systolic Function After CoreValve Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2016 Jun;9(6):e003425. doi: 10.1161/CIRCINTERVENTIONS.115.003425.'}, {'pmid': '27050187', 'type': 'DERIVED', 'citation': 'Deeb GM, Reardon MJ, Chetcuti S, Patel HJ, Grossman PM, Yakubov SJ, Kleiman NS, Coselli JS, Gleason TG, Lee JS, Hermiller JB Jr, Heiser J, Merhi W, Zorn GL 3rd, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Maini B, Mumtaz M, Conte J, Resar J, Aharonian V, Pfeffer T, Oh JK, Qiao H, Adams DH, Popma JJ; CoreValve US Clinical Investigators. 3-Year Outcomes in High-Risk Patients Who Underwent Surgical or Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2016 Jun 7;67(22):2565-74. doi: 10.1016/j.jacc.2016.03.506. Epub 2016 Apr 3.'}, {'pmid': '26764063', 'type': 'DERIVED', 'citation': 'Reynolds MR, Lei Y, Wang K, Chinnakondepalli K, Vilain KA, Magnuson EA, Galper BZ, Meduri CU, Arnold SV, Baron SJ, Reardon MJ, Adams DH, Popma JJ, Cohen DJ; CoreValve US High Risk Pivotal Trial Investigators. Cost-Effectiveness of Transcatheter Aortic Valve Replacement With a Self-Expanding Prosthesis Versus Surgical Aortic Valve Replacement. J Am Coll Cardiol. 2016 Jan 5;67(1):29-38. doi: 10.1016/j.jacc.2015.10.046.'}, {'pmid': '26508386', 'type': 'DERIVED', 'citation': 'Oh JK, Little SH, Abdelmoneim SS, Reardon MJ, Kleiman NS, Lin G, Bach D, Gillam L, Kar B, Coselli J, Sengupta PP, Grewal K, Chang J, Chang Y, Boulware M, Adams DH, Popma JJ; CoreValve U.S. Pivotal Trial Clinical Investigators. Regression of Paravalvular Aortic Regurgitation and Remodeling of Self-Expanding Transcatheter Aortic Valve: An Observation From the CoreValve U.S. Pivotal Trial. JACC Cardiovasc Imaging. 2015 Dec;8(12):1364-1375. doi: 10.1016/j.jcmg.2015.07.012. Epub 2015 Oct 26.'}, {'pmid': '26383718', 'type': 'DERIVED', 'citation': 'Yakubov SJ, Adams DH, Watson DR, Reardon MJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Schreiber T, Gleason TG, Conte J, Deeb GM, Huang J, Oh J, Byrne T, Caskey M, Popma JJ; CoreValve United States Clinical Investigators. 2-Year Outcomes After Iliofemoral Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis Deemed Extreme Risk for Surgery. J Am Coll Cardiol. 2015 Sep 22;66(12):1327-34. doi: 10.1016/j.jacc.2015.07.042.'}, {'pmid': '26292584', 'type': 'DERIVED', 'citation': 'Arnold SV, Reynolds MR, Wang K, Magnuson EA, Baron SJ, Chinnakondepalli KM, Reardon MJ, Tadros PN, Zorn GL, Maini B, Mumtaz MA, Brown JM, Kipperman RM, Adams DH, Popma JJ, Cohen DJ; CoreValve US Pivotal Trial Investigators. Health Status After Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Increased Surgical Risk: Results From the CoreValve US Pivotal Trial. JACC Cardiovasc Interv. 2015 Aug 17;8(9):1207-1217. doi: 10.1016/j.jcin.2015.04.018.'}, {'pmid': '26055947', 'type': 'DERIVED', 'citation': 'Reardon MJ, Adams DH, Kleiman NS, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Lee JS, Hermiller JB Jr, Chetcuti S, Heiser J, Merhi W, Zorn GL 3rd, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Maini B, Mumtaz M, Conte JV, Resar JR, Aharonian V, Pfeffer T, Oh JK, Qiao H, Popma JJ. 2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2015 Jul 14;66(2):113-21. doi: 10.1016/j.jacc.2015.05.017. Epub 2015 Jun 5.'}, {'pmid': '25700755', 'type': 'DERIVED', 'citation': 'Osnabrugge RL, Arnold SV, Reynolds MR, Magnuson EA, Wang K, Gaudiani VA, Stoler RC, Burdon TA, Kleiman N, Reardon MJ, Adams DH, Popma JJ, Cohen DJ; CoreValve U.S. Trial Investigators. Health status after transcatheter aortic valve replacement in patients at extreme surgical risk: results from the CoreValve U.S. trial. JACC Cardiovasc Interv. 2015 Feb;8(2):315-323. doi: 10.1016/j.jcin.2014.08.016.'}, {'pmid': '25152474', 'type': 'DERIVED', 'citation': 'Reardon MJ, Adams DH, Coselli JS, Deeb GM, Kleiman NS, Chetcuti S, Yakubov SJ, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Khabbaz K, Tadros P, Zorn GL 3rd, Merhi W, Heiser J, Petrossian G, Robinson N, Maini B, Mumtaz M, Lee JS, Gleason TG, Resar J, Conte J, Watson D, Chenoweth S, Popma JJ; CoreValve US Clinical Investigators. Self-expanding transcatheter aortic valve replacement using alternative access sites in symptomatic patients with severe aortic stenosis deemed extreme risk of surgery. J Thorac Cardiovasc Surg. 2014 Dec;148(6):2869-76.e1-7. doi: 10.1016/j.jtcvs.2014.07.020. Epub 2014 Jul 30.'}, {'pmid': '24678937', 'type': 'DERIVED', 'citation': 'Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.'}, {'pmid': '24657695', 'type': 'DERIVED', 'citation': 'Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Kafi A, Schreiber T, Gleason TG, Conte J, Buchbinder M, Deeb GM, Carabello B, Serruys PW, Chenoweth S, Oh JK; CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014 May 20;63(19):1972-81. doi: 10.1016/j.jacc.2014.02.556. Epub 2014 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or very high risk for aortic valve surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Extreme Risk Only: Subject must have comorbidities such that one cardiologist and two cardiac surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement. Specifically, the predicted operative risk of death or serious, irreversible morbidity is ≥ 50% at 30 days.\n* High Risk Surgical Only: Subject must have comorbidities such that one cardiologist and two cardiac surgeons agree that predicted risk of operative mortality is ≥15% (and predicted operative mortality or serious, irreversible morbidity risk of \\< 50%) at 30 days.\n* Subject has senile degenerative aortic valve stenosis with: mean gradient \\> 40 mmHg, or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac catheterization (either resting or dobutamine stress), AND an initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤ 0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization\n* Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater.\n* The subject or the subject's legal representative has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site.\n* The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.\n\nExclusion Criteria:\n\nClinical\n\n* Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.\n* Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the intended treatment. (High Risk Surgical Only: Including bare metal stents. Additionally, any drug eluting stents placed within 6 months prior to the index procedure.)\n* Blood dyscrasias as defined: leukopenia (WBC \\< 1000mm3), thrombocytopenia (platelet count \\<50,000 cells/mm3), history of bleeding diathesis or coagulopathy.\n* Untreated clinically significant coronary artery disease requiring revascularization.\n* Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.\n* Need for emergency surgery for any reason.\n* Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \\< 20% as measured by resting echocardiogram.\n* Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).\n* End stage renal disease requiring chronic dialysis or creatinine clearance \\< 20 cc/min.\n* Active Gastrointestinal (GI) bleeding within the past 3 months.\n* A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:\n* Aspirin\n* Heparin (HIT/HITTS)\n* Bivalirudin (Extreme Risk Only)\n* Nitinol (titanium or nickel)\n* Ticlopidine and clopidogrel\n* Contrast media\n* Ongoing sepsis, including active endocarditis.\n* Subject refuses a blood transfusion.\n* Life expectancy \\< 12 months due to associated non-cardiac co-morbid conditions.\n* Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.\n* Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).\n* Currently participating in an investigational drug or another device trial.\n* Symptomatic carotid or vertebral artery disease.\n* Subject has been offered surgical aortic valve replacement but declined. (High Risk Surgical Only)\n\nAnatomical\n\n* Native aortic annulus size \\< 18 mm or \\> 29 mm per the baseline diagnostic imaging.\n* Pre-existing prosthetic heart valve any position.\n* Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation (3-4+)).\n* Moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation.\n* Moderate to severe mitral stenosis.\n* Hypertrophic obstructive cardiomyopathy.\n* New or untreated echocardiographic evidence of intracardiac mass, thrombus or vegetation.\n* Severe basal septal hypertrophy with an outflow gradient.\n* Aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) \\> 70° (for femoral and left subclavian/axillary access) and \\> 30° (for right subclavian/axillary access).\n* Ascending aorta diameter \\> 43 mm if the aortic annulus diameter is 23-29 mm; ascending aorta diameter \\> 40 mm if the aortic annulus diameter is 20-23 mm; or an ascending aorta diameter \\> 34 mm if the aortic annulus diameter is 18-20 mm.\n* Congenital bicuspid or unicuspid valve verified by echocardiography.\n* Sinus of valsalva anatomy that would prevent adequate coronary perfusion.\n\nVascular\n\n\\- Transarterial access not able to accommodate an 18Fr sheath."}, 'identificationModule': {'nctId': 'NCT01240902', 'briefTitle': 'Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiovascular'}, 'officialTitle': 'Medtronic CoreValve® U.S. Pivotal Trial', 'orgStudyIdInfo': {'id': 'MCV-US-2009-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extreme Risk: TAVI Iliofemoral', 'description': 'Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); 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CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)', 'type': 'DEVICE', 'description': 'Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)', 'armGroupLabels': ['Extreme Risk: TAVI Iliofemoral', 'Extreme Risk: TAVI Non-Iliofemoral', 'High Risk: TAVI']}, {'name': 'Surgical Aortic Valve Replacement (SAVR)', 'type': 'DEVICE', 'description': 'Surgical Aortic Valve Replacement (SAVR)', 'armGroupLabels': ['High Risk: SAVR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Good Samaritan', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente - Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of 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