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 @ 5:54 PM
Ignite Modification Date: 2025-12-25 @ 3:18 PM
NCT ID: NCT01750268
Description: None
Frequency Threshold: 0
Time Frame: From enrollment through study completion, an average of 12 weeks
Study: NCT01750268
Study Brief: Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI
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 Placebo capsules daily - up 300 mg Medical Management Counseling: Brief alcohol and medication counseling Placebo: Placebo comparator 0 None 1 17 17 17 View
Topiramate Topiramate capsules daily - up to 300 mg Medical Management Counseling: Brief alcohol and medication counseling Topiramate: Experimental medication 0 None 3 15 15 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Inpatient medical hospitalization for an episode of chest pain in the context of cocaine use SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Voluntary psych inpatient admission due to homicidal ideation in the context of heavy cocaine use SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Inpatient medical hospitalization due to alcohol withdrawal SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Inpatient medical hospitalization for planned distal pancreatectomy and splenectomy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Numbness and tingling SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Change in sense of taste SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Loss of appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Difficulty with concentration and attention SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Difficulty with memory SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sleepiness SYSTEMATIC_ASSESSMENT General disorders None View
Slow thinking SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abnormal vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Language problems SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal thoughts and actions SYSTEMATIC_ASSESSMENT Psychiatric disorders None View