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 @ 2:20 AM
Ignite Modification Date: 2025-12-26 @ 12:52 AM
NCT ID: NCT02337634
Description: The definition of adverse events in this study matches the clinicaltrials.gov definition.
Frequency Threshold: 1
Time Frame: Adverse events were collected from the time participants signed consent until their final Week 8 visit.
Study: NCT02337634
Study Brief: Milk Thistle in Pathological Gambling
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Matched dosage of milk thistle daily. Placebo: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study. 0 None 0 26 3 26 View
Milk Thistle Capsule form, 150mg BID to 300mg BID Milk Thistle: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study. 0 None 0 17 4 17 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Reduced appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Increased appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View