Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:20 PM
Ignite Modification Date: 2025-12-25 @ 1:40 PM
NCT ID: NCT00041392
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00041392
Study Brief: Effects of Magnesium on Individuals Undergoing Coronary Artery Bypass Graft 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
Magnesium 100 mg/kg magnesium None None 37 198 137 198 View
0.9 % Saline 100 mg/kg 0.9 % saline None None 32 191 109 191 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fever None Immune system disorders None View
Atrial fibrillation None Cardiac disorders None View
Ventricular tachycardia None Cardiac disorders None View
Pacemaker placement None Cardiac disorders None View
Myocardial infarction None Cardiac disorders None View
Congestive heart failure None Cardiac disorders None View
Hypotension None Cardiac disorders None View
Cardiac death None Cardiac disorders None View
Small bowel obstruction None Gastrointestinal disorders None View
Urinary tract infection None Infections and infestations None View
Bleeding None Blood and lymphatic system disorders None View
Sternal wound infection None Infections and infestations None View
Stroke None Nervous system disorders None View
Pneumonia None Infections and infestations None View
Pleural effusion None Respiratory, thoracic and mediastinal disorders None View
Respiratory distress None Respiratory, thoracic and mediastinal disorders None View
Renal insufficiency None Renal and urinary disorders None View
Cardiac arrest None Cardiac disorders None View
GI bleed None Gastrointestinal disorders None View
Reexploration for bleeding None Surgical and medical procedures None View
Cellulitis None Infections and infestations None View
Respiratory failure None Respiratory, thoracic and mediastinal disorders None View
Renal failure None Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Renal Insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Postoperative bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypotension None Cardiac disorders None View
Anemia None Cardiac disorders None View
Atrial fibrillation None Cardiac disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View