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 @ 11:50 PM
Ignite Modification Date: 2025-12-25 @ 9:45 PM
NCT ID: NCT01235351
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01235351
Study Brief: Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CYP2C19*2 Carriers 75 mg Patient with a carrier of genotype given 75 mg of the drug None None 1 82 0 82 View
CYP2C19*2 Carriers 150 mg Patient with a carrier of genotype given 150 mg of the drug None None 5 82 0 82 View
CYP2C19*2 Carriers 225 mg Patient with a carrier of genotype given 225 mg of the drug None None 0 82 0 82 View
CYP2C19*2 Carriers 300mg Patient with a carrier of genotype given 300 mg of the drug None None 0 82 0 82 View
CYP2C19*2 Noncarriers 75 mg Patients who are non-carriers of the genotype given 75 mg of the drug None None 24 233 0 233 View
CYP2C19*2 Noncarriers 150 mg Patients who are non-carriers of the genotype given 150 mg of the drug None None 16 233 0 233 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Blood and lymphatic system disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Injury, poisoning and procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular disorders SYSTEMATIC_ASSESSMENT Vascular disorders None View
Cardiac disorders SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General disorders and administration site conditions SYSTEMATIC_ASSESSMENT General disorders None View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory, thoracic and mediastinal disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):