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 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:24 AM
NCT ID: NCT01361594
Description: 3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.
Frequency Threshold: 0
Time Frame: None
Study: NCT01361594
Study Brief: Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass 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
Intensive Insulin Treatment Intensive insulin treatment (BG target: 100-140 mg/dL) Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL None None 63 151 56 151 View
Conventional Insulin Treatment Conventional insulin treatment (BG target: 141-180 mg/dl) Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl None None 78 151 50 151 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute renal failure None Renal and urinary disorders None View
Respiratory Failure None Respiratory, thoracic and mediastinal disorders None View
Pneumonia None Respiratory, thoracic and mediastinal disorders None View
Major Adverse Cardiac Events (MACE) None Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Surgical re-intervention None Cardiac disorders None View
ICU Re-admission None Injury, poisoning and procedural complications None View
Hypoglycemia (ICU) None Endocrine disorders None View
Hypoglycemia (immediately after treatment) None Endocrine disorders None View