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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 3:45 AM

Ignite Modification Date: 2025-12-26 @ 2:32 AM

Study NCT ID: NCT05252702

Status: ACTIVE_NOT_RECRUITING

Last Update Posted: 2025-08-15

First Post: 2022-02-09

Is NOT Gene Therapy: False

Has Adverse Events: True

Brief Title: Aveir DR i2i Study

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D012804', 'term': 'Sick Sinus Syndrome'}, {'id': 'D054537', 'term': 'Atrioventricular Block'}, {'id': 'D019462', 'term': 'Syncope, Vasovagal'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001146', 'term': 'Arrhythmia, Sinus'}, {'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D054971', 'term': 'Orthostatic Intolerance'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013575', 'term': 'Syncope'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nicole.harbert@abbott.com', 'phone': '972-526-4841', 'title': 'Nicole Harbert, Director of Clinical Research', 'organization': 'Abbott Medical Devices, Cardiac Rhythm Management'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From implant attempt to last subject follow-up, ranging from 0 to 24 months', 'description': 'Adverse event data includes both device and non-device related events.', 'eventGroups': [{'id': 'EG000', 'title': 'Enrolled de Novo Cohort With Attempted Implant', 'description': 'The enrolled de novo cohort with attempted implant group consisted of subjects that were screened for and met eligibility criteria, provided written informed consent, and had an attempted dual chamber Aveir DR leadless pacemaker system implant', 'otherNumAtRisk': 452, 'deathsNumAtRisk': 452, 'otherNumAffected': 366, 'seriousNumAtRisk': 452, 'deathsNumAffected': 16, 'seriousNumAffected': 202}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 41, 'numAffected': 34}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiac Arrhythmia - Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 40, 'numAffected': 37}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 36, 'numAffected': 34}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Covid-19 Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 30, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Infection, Local at Access Site, or Systemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 25, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Urinary Tract Infection/UTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Chest Pain - Non-Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Accidental Injury/Mechanical Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiac Arrhythmia - Supraventricular Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Renal Failure/Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiac Arrhythmia - Ventricular Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Electrolyte Disbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pulmonary Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Valve Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Access Site Bleeding Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Aortic Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Gastrointestinal Bleeding/Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Groin Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Oversensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pericardial Effusion or Rub', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Peripheral Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pre-Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Transient Ischemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Lower Extremity Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pre-Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Shortness of Breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Chest Pain - Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Elevated D-Dimer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Skin Lesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Skin Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Thyroid Leves Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Adjustment Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Allergic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Altered Mental State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Asteatosis Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Asthmatic Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': "Barrett's Esophagus", 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Bilateral Upper Limb Numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Blurred Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Carpal Tunnel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Chest Pain Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Chest Pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Chest TIghtness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Chronic Dislocated Right Shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cirrhotic Liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Coccyx Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Deterioration of Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Drug-Induced Parkinsonism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Dysautonomia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Erectile Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Exacerbation of Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Eye Floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Eye Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Fistula Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Fluid Overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Frontoparietal Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Gastroesophageal Reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hepatic Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hot Flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Humerus Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Ingrown Toenail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Left Arm Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Left Hand Numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Leg Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Low Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Lung Nodules', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Nodules Right Thyroid Gland', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Numbness/Tingling in Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Ophthalmic Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Oral Ulcers', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pacemaker Mediated Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pansinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Patent Foramen Ovale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Periodontal Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Post-Operative Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pressure in the Head', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pressure Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pulmonary Nodules', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Qt Prolongation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Rapid Heart Rate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Rectal Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Restless Leg Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Rib Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Right Second Toe Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Skin Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Stasis Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Sublingual Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Thyroglossal Duct Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Tinea Cruris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Tongue Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Tympan Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Ulcerative Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Unsteady Gait', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Urinary Hesitancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Varicose Veins', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Vein Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Venous Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Venous Reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Vision Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Wrist Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Threshold Elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Intermitted or Loss of I2i Communication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hematoma Formation, Including Retroperitoneal Hematoma/Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Inability to Interrogate or Program due to Programmer or LP Malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Phrenic Nerve/Diaphragmatic/Extra-Cardiac Stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Intermittent Capture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pacemaker Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Failure to Capture/Loss of Capture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Tricuspid Valve Damage and/or Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Interruption of Desired LP Function due to Electrical Interference, Electromyogenic or Electromagnet', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Undersensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'False Magnet Mode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Intermittent or Loss of Sensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Access Site Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Access Site Oozing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Vascular Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Inability to Release and Redock the LP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Non-Healing Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Inability to Interrogate Device Due to Interference from Swan Ganz Continuous Cardiac Output Monitor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Left Ventricular Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'LP Found in Rom Mode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Access Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Radial Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Visual Hallucinations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Right Bundle Branch Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}], 'seriousEvents': [{'term': 'Cardiac Arrhythmia - Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 44, 'numAffected': 41}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiac Arrhythmia - Supraventricular Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Infection, Local at Access Site, or Systemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Accidental Injury/Mechanical Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Respiratory Failure/Respiratory Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Electrolyte Disbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Urinary Tract Infection/UTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Chest Pain - Non-Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Covid-19 Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Malignant Tumor/Malignant Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Renal Failure/Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Peripheral Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Transient Ischemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Valve Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiac Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Gastrointestinal Bleeding/Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pre-Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiac Arrhythmia - Ventricular Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Excessive Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Gallbladder Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hematoma Formation, Including Retroperitoneal Hematoma/Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pneumothorax/Hemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Reaction/Toxic Effect Due to Contrast Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Altered Mental Status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Femur Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Fluid Overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': "Parkinson's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Mechanical Device Dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pulmonary Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Acute Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Acute Psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Adjustment Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Anal Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Av Fistula Malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Calciphylaxis of Penis Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Carotid Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Chest Pain Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Chronic Right Elbow Olecranon Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Coxarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Enlarged Prostate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Gastroesophageal Reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Generalized Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Gonarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Head Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Ileitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Knee Arthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Left Atrial Appendage Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Leg Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Low Ejection Fraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Lumbar Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Lumbar Spinal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Parotid Tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pseudophakia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Sacroiliac Join Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Small Bowel Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Squamous Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Stent Restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Suicidal Ideations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Thyroid Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Vertebrae Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Vision Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Threshold Elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Inadequate Fixation During Implant with LP Migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Inadequate Fixation During Implant Without LP Migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pericardial Effusion or Rub', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Access Site Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Intermittent Capture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Tricuspid Valve Damage And/or Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pacemaker Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Intermittent or Loss of I2i Communication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Oversensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Arteriovenous Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiac Tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Inability to Release and Redock the LP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'False Magnet Mode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiopulmonary Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Access site Oozing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Arterial Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Cardiogenic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Complete Heart Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Device Dislogdement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}, {'term': 'Complete AV Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard Terminology'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Free From Aveir DR System-Related Complications at 3-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Population', 'description': 'The first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.3', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '93.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'binomial proportion', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '90.3', 'ciLowerLimit': '87', 'pValueComment': 'The CFR was estimated as a binomial proportion and a one-sided 97.5% lower confidence bound of the CFR was calculated using the normal approximation. The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG', 'statisticalMethod': 'one-sided Z-test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The p-value from a one-sided Z-test for the binomial proportion was calculated and compared to the 0.025 significance level.', 'nonInferiorityComment': 'The primary safety endpoint hypothesis at 3 months was formally expressed as:\n\nH0: CFR ≤ 78% vs. H1: CFR \\> 78%\n\nwhere 78% was the performance goal (PG).'}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population for the primary safety endpoint was based on subjects in the full analysis population. The full analysis population included the first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant. A de novo subject was a subject who did not have an implanted pacemaker on the date of consent through the date of the attempted Aveir LP implant'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Free From Aveir DR System-Related Complications at 12-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Population', 'description': 'The first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000', 'lowerLimit': '84.5', 'upperLimit': '91.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Kaplan-Meier', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '88.6', 'ciLowerLimit': '84.5', 'pValueComment': 'The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the Performance Goal (PG) of 76.5%.', 'statisticalMethod': 'one-sided Z-test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The p-value for the one-sided Z-test was calculated and compared to the 2.5% significance level.', 'nonInferiorityComment': 'The primary safety endpoint hypothesis at 12 months was formally expressed as:\n\nH0: CFR ≤ 76.5% vs. H1: CFR \\> 76.5%\n\nwhere 76.5% is the performance goal. The CFR was estimated using a Kaplan-Meier survival analysis and the 97.5% lower confidence bound of CFR was calculated using the Greenwood variance estimates.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population for the primary safety endpoint was based on subjects in the full analysis population. The full analysis population included the first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant. A de novo subject was a subject who did not have an implanted pacemaker on the date of consent through the date of the attempted Aveir LP implant.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 3-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Population', 'description': 'The first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.8', 'groupId': 'OG000', 'lowerLimit': '87.5', 'upperLimit': '94.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'binomial proportion', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '90.8', 'ciLowerLimit': '87.5', 'pValueComment': 'The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 82.5%.', 'groupDescription': 'The primary effectiveness endpoint #1 hypothesis at 3 month was formally expressed as:\n\nH0: Rate ≤ 82.5% vs. H1: Rate \\> 82.5%\n\nwhere 82.5% was the performance goal (PG).', 'statisticalMethod': 'one-sided Z-test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.'}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the primary effectiveness endpoint #1 if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 3-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 3-month visit.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the 300 subjects in the full analysis population, 3 subjects were excluded due to unsuccessful atrial device implant and unmeasurable p-wave amplitude.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 12-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Population', 'description': 'The first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.8', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '95.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'binomial proportion', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '92.8', 'ciLowerLimit': '89.7', 'pValueComment': 'The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 80%.', 'estimateComment': 'The Rate at 12 months was estimated as a binomial proportion and the one-sided 97.5% LCB of the Rate was calculated using the normal approximation.', 'groupDescription': 'The primary effectiveness endpoint #1 hypothesis at 12 months was formally expressed as:\n\nH0: Rate ≤ 80% vs. H1: Rate \\> 80%\n\nwhere 80% was the performance goal (PG).', 'statisticalMethod': 'one-sided Z-test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the success criteria for the endpoint if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 12-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 12-month visit.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of 300 subjects, 8 subjects were excluded from primary effectiveness endpoint. 2 were excluded for unsuccessful atrial device implant and 6 were excluded due to unmeasurable P-wave amplitudes and pacing voltages at the 12-month visit due to atrial fibrillation/ atrial tachycardia.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With AV Synchrony Success Rate at Rest While Seated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Population', 'description': 'The first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '99.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'binomial proportion', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '98.2', 'ciLowerLimit': '96.6', 'pValueComment': 'The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 83%.', 'groupDescription': 'The primary effectiveness endpoint #2 hypothesis was formally expressed as:\n\nH0: RateAV ≤ 83% vs. H1: RateAV \\> 83%\n\nwhere 83% is the performance goal.', 'statisticalMethod': 'one-sided Z-test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.'}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'AV synchrony success was defined as subjects with a paced or sensed ventricular beat within 300 ms following a paced or sensed atrial beat (i.e., a synchronous cycle) for at least 70% of evaluable cardiac cycles.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of 300 subjects in the full analysis population, 2 were excluded due to unsuccessful atrial implants. Then out of 298 subjects, 277 subjects with AV Synchrony data available to define endpoint success were included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 3-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Population', 'description': 'The first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.3', 'groupId': 'OG000', 'lowerLimit': '88.1', 'upperLimit': '94.5'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000'], 'paramType': 'binomial proportion', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '91.3', 'ciLowerLimit': '88.1', 'pValueComment': 'The null hypothesis was to be rejected at the 2.5% significance level if the lower confidence bound exceeded the Performance Goal (PG) of 84%.', 'groupDescription': 'The secondary safety endpoint hypothesis at 3 months was formally expressed as:\n\nH0: CFRA ≤ 84% vs. H1: CFRA \\> 84%\n\nwhere 84% was the performance goal.', 'statisticalMethod': 'one-sided Z-test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The p-value from a one-sided Z-test for the binomial proportion was to be calculated and compared to the 0.025 significance level.'}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'The secondary safety endpoint evaluated a 3-month Atrial LP related complication-free rate based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population for the secondary safety endpoint was based on subjects in the full analysis population, which included the first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 12-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Analysis Population', 'description': 'The first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000', 'lowerLimit': '87.1', 'upperLimit': '93.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Kaplan-Meier', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '91.0', 'ciLowerLimit': '87.1', 'pValueComment': 'The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the Performance Goal (PG) of 82%.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.7', 'estimateComment': 'The 97.5% lower confidence bound (LCB) of CFRA was calculated using the Greenwood variance estimates.', 'groupDescription': 'The secondary safety endpoint hypothesis at 12 months was formally expressed as:\n\nH0: CFRA ≤ 82% vs. H1: CFRA \\> 82%\n\nwhere 82% is the performance goal.', 'statisticalMethod': 'one-sided Z-test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The secondary safety endpoint analysis evaluated the 12-month Atrial LP related complication-free rate (CFRA) based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications. Complications possibly related or related to COVID-19 were excluded.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for the secondary safety endpoint was based on subjects in the full analysis population, which included the first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.'}, {'type': 'SECONDARY', 'title': 'Slope of the Normalized Increase in the Sensor Indicated Rate Versus Normalized Workload of the Aveir Atrial Leadless Pacemaker During Exercise Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronotropic Assessment Exercise Protocol (CAEP) Group', 'description': 'Data from subjects who had completed the 6MWT protocol and had completed at least stage 3 of the CAEP exercise protocol, or 3.6 metabolic equivalent of task (METs), were included in the analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '1.04'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'mixed effects model for repeated measure', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'groupDescription': 'An analysis of these data provided an estimate of the 95% confidence interval for the mean slope across analyzable subjects, which had a pre-specified success criterion requiring that this confidence interval must fall between slopes of 65% and 135%. The following hypothesis was evaluated:\n\nH0: Mean Slope \\< 0.65 or Mean Slope \\> 1.35\n\nH1: 0.65 ≤ Mean Slope ≤ 1.35', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Two one-sided t-tests (TOST), with an alpha level of 0.025, and n-1 degrees of freedom.'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': "Appropriate and proportional rate response of the Aveir Atrial Leadless Pacemaker in de novo subjects was tested during staged exercise testing. Exercise test data provided an estimate of the slope of the normalized increase in sensor-indicated rate versus normalized workload for each subject. Normalizing a variable eliminates the unit and expresses it from 0-1.0. Since both axes are normalized sensor rate and workload, there is no distinct unit of measure. Values on the vertical axis are derived from the difference of the sensor indicated rate at each exercise stage and the base rate, divided by the difference of the age-predicted maximum heart rate and base rate. Values on the horizontal axis are derived from the difference in the workload at each exercise stage and resting workload, divided by the difference of the maximum achieved workload and resting workload. A slope value of 1.0 indicates the pacemaker's sensor-indicated rate increases linearly with an increase in workload.", 'unitOfMeasure': 'unitless', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with Analyzable CAEP Data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enrolled de Novo Cohort', 'description': 'The enrolled de novo cohort consisted of subjects that were screened for and met eligibility criteria, provided written informed consent, and were scheduled to undergo a dual chamber Aveir DR leadless pacemaker system implant wherein a leadless pacemaker was to be implanted in the right ventricle and right atrium'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Enrolled subjects', 'achievements': [{'groupId': 'FG000', 'numSubjects': '464'}]}, {'type': 'Attempted Implant', 'achievements': [{'groupId': 'FG000', 'numSubjects': '452'}]}, {'type': 'Predischarge Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '450'}]}, {'type': '1-month Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '443'}]}, {'type': '3-month Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '442'}]}, {'type': '6-month Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '435'}]}, {'type': '12-month Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '360'}]}, {'type': '18-month Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'comment': '24-month Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '434'}]}], 'dropWithdraws': [{'type': 'No attempted implant, subjects withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'System explant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawn by investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Visit not due', 'reasons': [{'groupId': 'FG000', 'numSubjects': '306'}]}, {'type': 'Visit within window but not completed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '92'}]}, {'type': 'Unsuccessful implant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subject enrollment in the Aveir DR i2i IDE study began on February 2, 2022 in Czech Republic, February 24, 2022 in the US, April 7, 2022 in Canada, October 14, 2022 in Hong Kong, and February 9, 2023 in Taiwan. The study enrolled 464 de novo subjects at 77 sites worldwide'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '452', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enrolled de Novo Cohort With Attempted Implant', 'description': 'The enrolled de novo cohort with attempted implant group consisted of subjects that were screened for and met eligibility criteria, provided written informed consent, and had an attempted dual chamber Aveir DR leadless pacemaker system implant'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.8', 'spread': '13.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '174', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '278', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '282', 'groupId': 'BG000'}]}]}, {'title': 'Declined/Unable to Disclose', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Multi-Racial', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '331', 'groupId': 'BG000'}]}]}, {'title': 'Declined/Unable to Disclose', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '280', 'groupId': 'BG000'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '170.7', 'spread': '10.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '81.6', 'spread': '19.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'spread': '5.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-28', 'size': 4098055, 'label': 'Study Protocol: Clinical Investigation Plan', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-26T18:47', 'hasProtocol': True}, {'date': '2022-11-23', 'size': 4206285, 'label': 'Study Protocol: Clinical Investigation Plan for Europe', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-26T18:48', 'hasProtocol': True}, {'date': '2022-08-12', 'size': 1733532, 'label': 'Statistical Analysis Plan: Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-26T18:48', 'hasProtocol': False}, {'date': '2022-09-22', 'size': 2009942, 'label': 'Statistical Analysis Plan: Statistical Analysis Plan for Europe', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-26T18:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, multi-center, international, single-arm, pivotal investigational study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 464}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2022-02-09', 'resultsFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2022-02-17', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-01', 'studyFirstPostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Free From Aveir DR System-Related Complications at 3-months', 'timeFrame': '3 months', 'description': 'Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.'}, {'measure': 'Percentage of Participants Free From Aveir DR System-Related Complications at 12-months', 'timeFrame': '12 months', 'description': 'Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.'}, {'measure': 'Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 3-months', 'timeFrame': '3 months', 'description': 'Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the primary effectiveness endpoint #1 if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 3-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 3-month visit.'}, {'measure': 'Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 12-months', 'timeFrame': '12 months', 'description': 'Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the success criteria for the endpoint if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 12-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 12-month visit.'}, {'measure': 'Percentage of Participants With AV Synchrony Success Rate at Rest While Seated', 'timeFrame': '3 months', 'description': 'AV synchrony success was defined as subjects with a paced or sensed ventricular beat within 300 ms following a paced or sensed atrial beat (i.e., a synchronous cycle) for at least 70% of evaluable cardiac cycles.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 3-months', 'timeFrame': '3 months', 'description': 'The secondary safety endpoint evaluated a 3-month Atrial LP related complication-free rate based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications.'}, {'measure': 'Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 12-months', 'timeFrame': '12 months', 'description': 'The secondary safety endpoint analysis evaluated the 12-month Atrial LP related complication-free rate (CFRA) based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications. Complications possibly related or related to COVID-19 were excluded.'}, {'measure': 'Slope of the Normalized Increase in the Sensor Indicated Rate Versus Normalized Workload of the Aveir Atrial Leadless Pacemaker During Exercise Testing', 'timeFrame': '3 months', 'description': "Appropriate and proportional rate response of the Aveir Atrial Leadless Pacemaker in de novo subjects was tested during staged exercise testing. Exercise test data provided an estimate of the slope of the normalized increase in sensor-indicated rate versus normalized workload for each subject. Normalizing a variable eliminates the unit and expresses it from 0-1.0. Since both axes are normalized sensor rate and workload, there is no distinct unit of measure. Values on the vertical axis are derived from the difference of the sensor indicated rate at each exercise stage and the base rate, divided by the difference of the age-predicted maximum heart rate and base rate. Values on the horizontal axis are derived from the difference in the workload at each exercise stage and resting workload, divided by the difference of the maximum achieved workload and resting workload. A slope value of 1.0 indicates the pacemaker's sensor-indicated rate increases linearly with an increase in workload."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Bradycardia', 'Sick Sinus Syndrome', 'Pacemaker', 'AV Block', 'Vasovagal Syncope'], 'conditions': ['Cardiac Pacemaker, Artificial', 'Cardiac Rhythm Disorder', 'Bradycardia']}, 'referencesModule': {'references': [{'pmid': '40143804', 'type': 'DERIVED', 'citation': 'Knops RE, Ip JE, Doshi R, Exner DV, Defaye P, Canby R, Bongiorni MG, Shoda M, Hindricks G, Neuzil P, Rashtian M, Breeman KTN, Nevo JR, Ganz L, Hubbard C, Bulusu A, Reddy VY. One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker. Circ Arrhythm Electrophysiol. 2025 Apr;18(4):e013619. doi: 10.1161/CIRCEP.124.013619. Epub 2025 Mar 27.'}, {'pmid': '40089049', 'type': 'DERIVED', 'citation': 'Doshi RN, Ip JE, Defaye P, Reddy VY, Exner DV, Canby R, Shoda M, Bongiorni MG, Hindricks G, Neuzil P, Callahan T, Sundaram S, Booth DF, Richer LP, Badie N, Knops RE. Dual-chamber leadless pacemaker implant procedural outcomes: Insights from the AVEIR DR i2i study. Heart Rhythm. 2025 Sep;22(9):2391-2400. doi: 10.1016/j.hrthm.2025.03.1941. Epub 2025 Mar 13.'}, {'pmid': '39581426', 'type': 'DERIVED', 'citation': 'Rashtian MY, Ip JE, Exner DV, Reddy VY, Doshi RN, Defaye P, Canby RC, Bongiorni MG, Shoda M, Hindricks G, Nevo JR, Ligon D, Bulusu A, Knops RE. Temperature-based rate response in a leadless pacemaker system. Heart Rhythm. 2025 Jun;22(6):1533-1540. doi: 10.1016/j.hrthm.2024.11.032. Epub 2024 Nov 22.'}, {'pmid': '39427688', 'type': 'DERIVED', 'citation': 'Doshi RN, Ip JE, Defaye P, Exner DV, Reddy VY, Hindricks G, Canby R, Shoda M, Bongiorni MG, Neuzil P, Callahan T, Badie N, Ligon D, Knops RE. Chronic wireless communication between dual-chamber leadless pacemaker devices. Heart Rhythm. 2025 Apr;22(4):1010-1020. doi: 10.1016/j.hrthm.2024.10.020. Epub 2024 Oct 19.'}, {'pmid': '37212442', 'type': 'DERIVED', 'citation': 'Knops RE, Reddy VY, Ip JE, Doshi R, Exner DV, Defaye P, Canby R, Bongiorni MG, Shoda M, Hindricks G, Neuzil P, Rashtian M, Breeman KTN, Nevo JR, Ganz L, Hubbard C, Cantillon DJ; Aveir DR i2i Study Investigators. A Dual-Chamber Leadless Pacemaker. N Engl J Med. 2023 Jun 22;388(25):2360-2370. doi: 10.1056/NEJMoa2300080. Epub 2023 May 20.'}, {'pmid': '36951813', 'type': 'DERIVED', 'citation': 'Reddy VY, Exner DV, Doshi R, Tomassoni G, Bunch TJ, Friedman P, Estes NAM, Neuzil P, de la Concha JF, Cantillon DJ; LEADLESS II Investigators. 1-Year Outcomes of a Leadless Ventricular Pacemaker: The LEADLESS II (Phase 2) Trial. JACC Clin Electrophysiol. 2023 Jul;9(7 Pt 2):1187-1189. doi: 10.1016/j.jacep.2023.01.031. Epub 2023 Mar 22. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.', 'detailedDescription': 'The purpose of this clinical investigation is to evaluate the clinical safety and effectiveness of the Aveir DR Leadless Pacemaker system in a patient population indicated for a DDD(R) pacemaker.\n\nSubjects participating in the study are followed through at least 12 months with data collected at baseline, implant procedure, pre (hospital) discharge, and follow-up at 1 month, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject must have at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines\n2. Subject is ≥ 18 years of age or age of legal consent, whichever age is greater\n3. Subject has a life expectancy of at least one year\n4. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams\n5. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC\n\nExclusion Criteria:\n\n1. Subject is currently participating in another clinical investigation that may confound the results of this study as determined by the Sponsor\n2. Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period\n3. Subject has presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could confound the assessment of the investigational device and/or implant procedure, limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results\n4. Subject has a known allergy or hypersensitivity to \\< 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material listed in the IFU\n5. Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis\n6. Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments)\n7. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device\n8. Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular leadless pacemaker)\n9. Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators)\n10. Subject is unable to read or write"}, 'identificationModule': {'nctId': 'NCT05252702', 'briefTitle': 'Aveir DR i2i Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Aveir Dual-Chamber Leadless i2i IDE Study', 'orgStudyIdInfo': {'id': 'ABT-CIP-10416'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Arm', 'description': 'Non randomized arm', 'interventionNames': ['Device: Aveir DR Leadless Pacemaker System']}], 'interventions': [{'name': 'Aveir DR Leadless Pacemaker System', 'type': 'DEVICE', 'description': 'Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'HonorHealth', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arrhythmia Research Group', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Heart Hospital', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'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': 'USC University Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 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{'city': 'Prague', 'country': 'Czechia', 'facility': 'Nemocnice Na Homolce', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '13005', 'city': 'Marseille', 'state': 'Alpes', 'country': 'France', 'facility': "Hopital d'adulte de la Timone", 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHRU Albert Michallon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Hong Kong', 'state': 'HK SAR', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': 'HK SAR', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '20138', 'city': 'Milan', 'country': 'Italy', 'facility': 'Centro Cardiologico Monzino', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '56100', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kokura Memorial Hospital', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Kurashiki-shi', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Kurashiki Central Hospital'}, {'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'National Cerebral & Cardiovascular Center Hospital', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': "Tokyo Women's Medical University", 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam Academic Medical Centre (AMC)', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '06080', 'city': 'Badajoz', 'state': 'Extmdra', 'country': 'Spain', 'facility': 'Hospital Universitario de Badajoz', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'state': 'Soeast', 'country': 'United Kingdom', 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'SW3 6NP', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Brompton Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Nicole Harbert', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'IPD will be available following publication of primary results for 25 years following study completion date.', 'ipdSharing': 'YES', 'description': 'Any de-identified individual participant data collected will be shared with investigators or other study committee members whose proposed use of the data has been approved by the Aveir DR i2i Study Steering Committee.', 'accessCriteria': 'Proposals for requesting individual data may be submitted to the Sponsor at AveirDR\\_IDE@abbott.com.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}