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: 2025-12-24 @ 9:58 PM
Ignite Modification Date: 2025-12-25 @ 7:36 PM
NCT ID: NCT03604432
Description: None
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT03604432
Study Brief: Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Group Elective cardiac surgery plus prophylactic maze procedure prophylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm 0 None 12 29 21 29 View
Control Group Elective cardiac surgery only 0 None 15 31 23 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory Infections/Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Res. Infection/ Pneu View
Covid 19 SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Covid-19 View
ulcerated aorta SYSTEMATIC_ASSESSMENT Vascular disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PEA Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
GI disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Miscellaneous SYSTEMATIC_ASSESSMENT General disorders None View
UTI SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Post op Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders Afib View
Acute Kidney Injury/ Acute Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders AKI View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Resp. Failure View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Anemia View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders Atrial flutter View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders Hematoma View
Thrombotic Event NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Conduit Issues SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiogenic Shock SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension/systemic SYSTEMATIC_ASSESSMENT Cardiac disorders None View
injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
neurological disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute brain infarct SYSTEMATIC_ASSESSMENT Vascular disorders None View
Carotid Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Resp. Failure View
Contusion NON_SYSTEMATIC_ASSESSMENT Vascular disorders Contusion View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Anemia View
Post op Afib SYSTEMATIC_ASSESSMENT Cardiac disorders post op Afib View
Elevated Creatine SYSTEMATIC_ASSESSMENT Renal and urinary disorders Elevated Creatine View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders Bradycardia View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations UTI View
Bone Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Bone fracture View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Hyponatremia View
Confusion/Delerium SYSTEMATIC_ASSESSMENT Nervous system disorders Confusion/Delerium View