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 @ 7:38 PM
Ignite Modification Date: 2025-12-25 @ 5:19 PM
NCT ID: NCT01287403
Description: None
Frequency Threshold: 5
Time Frame: This adverse event occurred during the 1st intervention. The subject did not wish to go on with the study.
Study: NCT01287403
Study Brief: Response of Alkylresorcinols to Different Cereals
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Esterase Wholegrain Wheat Flour A cereal flour treated with esterases to release phenolics (positive control for phenolic acids) None None 0 14 0 14 View
Liquid Whole Grain Wheat Flour A treated cereal flour mixed with milk. None None 0 14 0 14 View
Liquid Wholegrain Barley Flour A treated cereal flour mixed with milk. None None 0 14 0 14 View
Wholegrain Wheat Flour A treated cereal flour mixed with milk. None None 0 14 0 14 View
Wholegrain Barley Flour A treated cereal flour mixed with milk. None None 0 14 0 14 View
Refined Wheat Flour A treated cereal flour mixed with milk (negative control). None None 0 14 1 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Vomiting View