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: 2025-12-24 @ 11:09 PM
Ignite Modification Date: 2025-12-25 @ 8:43 PM
NCT ID: NCT03495869
Description: AE form/log
Frequency Threshold: 5
Time Frame: 1 month
Study: NCT03495869
Study Brief: Feasibility and Validation of a Standard Phenotyping Assessment Battery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Individuals With Cocaine Use Disorder This group will consist of individuals who are determined to have DSM5 diagnosis of Cocaine Use Disorder (n=50). Individuals will be recruited from an existing registry (VCU IRB HMHM20000294, Keyser-Marcus, PI) 0 None 0 50 0 50 View
Individuals With Opioid Use Disorder This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200). 0 None 1 97 0 97 View
Individuals With Marijuana Use Disorder This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50). 0 None 0 51 0 51 View
Healthy Controls This group will consist of individuals who are determined to be non-drug using healthy controls (n=100). 0 None 0 108 0 108 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
hospitalization SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):