Adverse Events Module

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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: 2025-12-26 @ 1:16 PM
Ignite Modification Date: 2025-12-26 @ 1:16 PM
NCT ID: NCT00106106
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00106106
Study Brief: Acamprosate to Reduce Symptoms of Alcohol Withdrawal
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 For subjects randomized to placebo control, placebo doses were given every 8 hours. None None 0 26 20 22 View
Acamprosate For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study. None None 1 23 18 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vaso-vagal faint None General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Impaired concentration SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lack of appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lack of energy SYSTEMATIC_ASSESSMENT General disorders None View
Mood swings SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nervousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sensation of prickling or tingling on the skin SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Shakiness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sleepiness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sleeplessness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stomach aches SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Decreased interest in sex SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Feeling Down SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headaches SYSTEMATIC_ASSESSMENT General disorders None View
Abnormal Dreaming SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders None View