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 @ 1:38 AM
Ignite Modification Date: 2025-12-25 @ 11:53 PM
NCT ID: NCT02389894
Description: None
Frequency Threshold: 5
Time Frame: 90 Days
Study: NCT02389894
Study Brief: Neuroprotection in Patients Undergoing 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
Embol-X Embolic Protection Device The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath. Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU). 4 None 72 133 45 133 View
CardioGard Cannula The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula. CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU). 5 None 53 118 47 118 View
Standard Cannula Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing. 3 None 54 132 43 132 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Kidney Injury - Stage 2 SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute Kidney Injury - Stage 3 SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bleeding - Transfusion > 5 units RBC <24 hours following surgery SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bleeding - Re-operation for hemorrhage or tamponade SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiac Arrhythmias - Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Arrhythmias - Sustained ventricular arrhythmia requiring defibrillation or cardioversion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Arrhythmias - Cardiac conduction abnormalities or sustained bradycardia requiring permanent SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial Fluid Collection SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hepatic Dysfunction (Liver injury and Impaired Liver function) SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Major Infection - Localized Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Major Infection - Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Major Infection - Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Myocardial Infarction - Non-Procedure Related SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial Infarction - Peri-CABG SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Neurological Dysfunction- Transient Ischemic Attack - TIA SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurological Dysfunction- Ischemic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurological Dysfunction- Toxic Metabolic Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurological Dysfunction- Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurological Dysfunction- Other Neurological Dysfunction* SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Renal Events (Renal Failure) SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Venous Thromboembolism Event - Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Venous Thromboembolism Event - Pulmonary Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Venous Thromboembolism Event - Other* SYSTEMATIC_ASSESSMENT Vascular disorders None View
Wound Dehiscence SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Adrenal Insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Aortic Valve Re-operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Appendicitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cholecystitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Disseminated Intravascular Coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dysphagia with PEG tube placement SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Fluid Overload SYSTEMATIC_ASSESSMENT General disorders None View
Foot Pain SYSTEMATIC_ASSESSMENT General disorders None View
GI Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypercapnia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Intra abdominal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lung mass SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Orthostatic Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumoperitoneum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Post-pericardiotomy Syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Repair of Aorta SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Severe TR requiring TV replacement SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Small bowel obstruction/ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Weakness SYSTEMATIC_ASSESSMENT General disorders None View
Acute Kidney Injury - Stage 1 SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acute Kidney Injury - Stage 1 SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Major Infection - Localized Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View