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: 2025-12-25 @ 5:11 AM
Ignite Modification Date: 2025-12-26 @ 4:16 AM
NCT ID: NCT00489827
Description: All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital
Frequency Threshold: 0
Time Frame: All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital
Study: NCT00489827
Study Brief: Glutamate for Metabolic Intervention in Coronary 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
Saline Infusion Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. 131 None 59 433 165 433 View
Intravenous Glutamate Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. 126 None 54 428 164 428 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stroke < 24 hours SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Severe circulatory failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Perioperative myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac mortality SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Postoperative dialysis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Reoperation for bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Postoperative mortality SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Postoperative nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Postoperative atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin reaction NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View