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 @ 1:05 AM
Ignite Modification Date: 2025-12-25 @ 11:17 PM
NCT ID: NCT04177693
Description: None
Frequency Threshold: 0
Time Frame: Up to 60 days
Study: NCT04177693
Study Brief: Pharmacokinetics and Hepatic Safety of EGCG
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
EGCG Daily Alone. EGCG daily alone. 800mg Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months 0 None 0 16 2 16 View
EGCG With Clomiphene Citrate EGCG 800 mg daily with clomiphene citrate 100mg for 5 days. Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months Clomiphene Citrate: 100 mg for 5 days 0 None 0 11 4 11 View
EGCG With Letrozole EGCG 800mg daily with letrozole 5mg for 5 days. Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months Letrozole: 5 mg for 5 days 0 None 0 12 6 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort and loose stool NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Facial flushing, muscle ache, and diarrhea after letrozole NON_SYSTEMATIC_ASSESSMENT General disorders None View
Greenish discharge NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Migraine after vaccine NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Headaches NON_SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Kidney pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Loose stool NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Low mood NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea with EGCG NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pelvic cramps, dull and intermittent aching after letrozole NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting and diarrhea after clomid NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View