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 @ 4:28 AM
Ignite Modification Date: 2025-12-26 @ 3:31 AM
NCT ID: NCT04287920
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from baseline to end of study, approximately 24 weeks.
Study: NCT04287920
Study Brief: Acamprosate Safe to Use in Individuals With Liver Disease.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months 0 None 0 6 0 6 View
Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months 0 None 0 6 1 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View