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: 2025-12-25 @ 2:12 AM
Ignite Modification Date: 2025-12-26 @ 12:40 AM
NCT ID: NCT03533660
Description: We collected data only on those who completed the intake interview and participated in the study (n=27). Data was collected from medical record review and information on device wearing issues was collected during monthly assessments. We tracked mortality, and number of hospitalizations and emergency room visits but our protocol was not to identify the causes/reasons for ER visit/hospitalizations. There were no serious adverse events related to the study.
Frequency Threshold: 0
Time Frame: Data was collected over the three month period that the participants participated in the study.
Study: NCT03533660
Study Brief: Alcohol Biosensor Monitoring for Alcoholic 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
Feedback Feedback: Participant will receive a brief feedback on alcohol use data downloaded from the ABM and information about treatment resources 2 None 0 14 7 14 View
Enhanced Usual Care Participant will receive information about remaining abstinent and about treatment resources 2 None 0 13 7 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
strap being itchy/scratchy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
skin irritation/indentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Uncomfortable SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Participants uncomfortable with device appearance SYSTEMATIC_ASSESSMENT Product Issues None View