Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:30 AM
Ignite Modification Date: 2025-12-26 @ 1:05 AM
NCT ID: NCT03173534
Description: None
Frequency Threshold: 0
Time Frame: Events collected within two years following randomization.
Study: NCT03173534
Study Brief: WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TAVR + Medical Therapy n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation TAVR: Transcatheter Aortic Valve Replacement 39 None 90 172 131 172 View
TAVR + WATCHMAN n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device. WATCHMAN: WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium. TAVR: Transcatheter Aortic Valve Replacement 37 None 87 177 127 177 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bleeding - Event Associated with bleeding NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders VARC 2 definitions View
Cardiac - Heart Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Renal - Other (not bleeding) NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders VARC 2 definitions View
Infection - Other (except endocarditis and device infection) NON_SYSTEMATIC_ASSESSMENT Infections and infestations VARC 2 definitions View
Cardiac - Sudden Cardiac Death/Cardiac Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Thrombosis - TAVR Device NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Rehospitalization related to WATCHMAN procedure or device (not listed above) NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Device Embolization - Catheter Retrieval NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Cardiac - Heart Valve Damage NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Thrombosis- Venous (including DVT) NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Thrombosis - TAVR Device NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Rehospitalization related to WATCHMAN procedure or device NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Any AE with symptoms that could possibly be contributed to WATCHMAN or TAVR device/procedure NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders VARC 2 definitions View
Cancer/Malignancy NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Pulmonary - Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders VARC 2 definitions View
Neurologic - Ischemic Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders VARC 2 definitions View
Pulmonary - Pleural Effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders VARC 2 definitions View
Neurologic - Other NON_SYSTEMATIC_ASSESSMENT Nervous system disorders VARC 2 definitions View
Supra-therapeutic INR NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Neurologic - Stroke Type Unknown NON_SYSTEMATIC_ASSESSMENT Nervous system disorders VARC 2 definitions View
Trauma NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Renal - AKI (requiring dialysis) NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders VARC 2 definitions View
Cardiac - Pericardial Effusion (not hemorrhagic) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
COVID-19 Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations VARC 2 definitions View
Rehospitalization related to TAVR device or procedure NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Infection - UTI NON_SYSTEMATIC_ASSESSMENT Infections and infestations VARC 2 definitions View
Thrombosis - Other systemic NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
GI- Other (not bleeding) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders VARC 2 definitions View
Cardiac - Endocarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
COD Unknown NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Pulmonary - Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders VARC 2 definitions View
Neurologic - TIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders VARC 2 definitions View
Cardiac - Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Pulmonary - Other NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders VARC 2 definitions View
Cardiac - AV Regurgitation/Leak NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Thrombosis - WATCHMAN Device NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Thrombus- Atrial (not arterial) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Septic Shock NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Endocrine Disorders NON_SYSTEMATIC_ASSESSMENT Endocrine disorders VARC 2 definitions View
Cardiac - Angina/Chest Pain/CAD NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Pulmonary - Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders VARC 2 definitions View
Pulmonary - COPD NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders VARC 2 definitions View
Neurologic - Subdural Hematoma NON_SYSTEMATIC_ASSESSMENT Nervous system disorders VARC 2 definitions View
Vascular Pseudoaneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Vascular AV Fistula (intervention required) NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Thrombosis - Other NON Cardiac Device NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Neruo- Mental Status Changes/Confusion (not stroke or TIA) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders VARC 2 definitions View
Cardiac - Heart Valve Damage NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Thrombosis - Venous (including DVT) NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Cardiac - Other NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Hepatobiliary (not bleeding) NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bleeding NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders VARC 2 definitions View
Cardiac - Other NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Rental NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders VARC 2 definitions View
Trauma NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations VARC 2 definitions View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders VARC 2 definitions View
Any AE with symptoms that could possibly be contributed to WATCHMAN or TAVR device/procedure NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Neurologic NON_SYSTEMATIC_ASSESSMENT Nervous system disorders VARC 2 definitions View
Infection - UTI NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders VARC 2 definitions View
Cancer/Malignancy NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Cardiac - Sudden Cardiac Death/Cardiac Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Neurologic - Ischemic Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders VARC 2 definitions View
Neurologic - TIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders VARC 2 definitions View
Pulmonary - Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders VARC 2 definitions View
Pulmonary - Other NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders VARC 2 definitions View
Cardiac - Angina/Chest Pain/CAD NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Pulmonary - Pleural Effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders VARC 2 definitions View
COVID-19 Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations VARC 2 definitions View
Pulmonary - Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders VARC 2 definitions View
COD Unknown NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Cardiac - Pericardial Effusion (not hemorrhagic) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Neurologic - Stroke Type Unknown NON_SYSTEMATIC_ASSESSMENT Nervous system disorders VARC 2 definitions View
Thrombosis - Venous (including DVT) NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Renal- AKI (requiring dialysis) NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders VARC 2 definitions View
Rehospitalization related to TAVR device or procedure (not listed) NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Thrombus - Atrial (not arterial) NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
GI- Other (not bleeding) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders VARC 2 definitions View
Cardiac - Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders VARC 2 definitions View
Endocrine Disorders NON_SYSTEMATIC_ASSESSMENT Endocrine disorders VARC 2 definitions View
Pulmonary - Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders VARC 2 definitions View
Neurologic - Subdural Hematoma NON_SYSTEMATIC_ASSESSMENT Nervous system disorders VARC 2 definitions View
Cardiac - AV Regurg/Leak NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Vascular Pseudoaneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Rehospitalization related to WATCHMAN procedure or device NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Pancreatic NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders VARC 2 definitions View
Thrombosis - WATCHMAN Device NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Septic Shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations VARC 2 definitions View
Cardiac - Atrial Septal Defect (latrogenic) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Device Embolization - Catheter Retrieval NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Pulmonary - COPD NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders VARC 2 definitions View
Vascular Pseudoaneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Vascular AV Fistual NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Neoplasm Benign & Malignant NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) VARC 2 definitions View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Cardiac - Heart Valve Damage NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Inflammatory/Immunologic NON_SYSTEMATIC_ASSESSMENT Infections and infestations VARC 2 definitions View
Thrombosis - TAVR Device NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Vascular AV Fistula NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Thrombosis - Other NON Cardiac Device NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Thrombosis - Other Cardiac Device NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View
Supra-therapeutic INR NON_SYSTEMATIC_ASSESSMENT General disorders VARC 2 definitions View
Hepatobiliary (not bleeding) NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders VARC 2 definitions View
Neurologic - Mental Status Changes/Confusion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders VARC 2 definitions View
Cardiac - Endocarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders VARC 2 definitions View
Thrombosis - Other Systemic (other than stroke) NON_SYSTEMATIC_ASSESSMENT Vascular disorders VARC 2 definitions View