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 All Studies All Organizations 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 @ 4:50 PM
Ignite Modification Date: 2025-12-24 @ 4:50 PM
NCT ID: NCT00368550
Description: Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.
Frequency Threshold: 5
Time Frame: 14 weeks
Study: NCT00368550
Study Brief: Sertraline Pharmacotherapy for Alcoholism Subtypes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sertraline Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit. None None 3 63 22 63 View
Placebo Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit. None None 0 71 14 71 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization due to chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization due to relapse to heavy drinking SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
sexual problems SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
tired/sleepy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
decreased appetite SYSTEMATIC_ASSESSMENT Nervous system disorders None View