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 @ 2:30 AM
Ignite Modification Date: 2025-12-26 @ 1:05 AM
NCT ID: NCT01532934
Description: Criminal recidivism is not considered an adverse event because it is one of the outcome variables. Participants were monitored for serious adverse events through six months of the study (i.e., the last study-related session). There were no adverse events.
Frequency Threshold: 0
Time Frame: Six months from baseline
Study: NCT01532934
Study Brief: The Impact of Psychopathic Traits on the Efficacy of a Substance Use Intervention
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Brief Motivational Intervention Plus Standard Care There were no adverse events for members of this group. None None 0 53 0 53 View
Standard Care There were no adverse events for members of this group. None None 0 52 0 52 View
Serious Events(If Any):
Other Events(If Any):