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 @ 12:59 AM
Ignite Modification Date: 2025-12-25 @ 11:12 PM
NCT ID: NCT02110693
Description: The all cause mortality and serious adverse event data refer to the total combined sample (n = 2,000). We report the total sample here because all participants received both the interviewer and self-administered versions one immediately after the other in one single session.
Frequency Threshold: 0
Time Frame: Baseline data only gathered in this study.
Study: NCT02110693
Study Brief: The Tobacco, Alcohol, Prescription Medication and Other Substances Tool
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Participants All participants enrolled in the study (because all participants were administered both the self-administered and the interviewer administered versions of the instrument, we are reporting adverse events for the total sample) 0 None 0 2000 16 2000 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood on oral swab SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View