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 Make This Study a Gene Therapy Make This Study a Not Gene Therapy 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 @ 11:32 PM
Ignite Modification Date: 2025-12-25 @ 9:21 PM
NCT ID: NCT05120856
Description: We were prepared to record if participants spontaneously reported significant emotional distress (e.g., feeling triggered, or experiencing strong cravings, during or after app use) at any time during the trial, but none did.
Frequency Threshold: 0
Time Frame: Since this trial tested a brief behavioural training task delivered in a smartphone app, we did not actively assess adverse events. We were prepared to record if participants spontaneously reported significant emotional distress (e.g., feeling triggered, or experiencing strong cravings, during or after app use) at any time during their participation (up to the final 16-week follow-up), but none reported any adverse events.
Study: NCT05120856
Study Brief: AAT-App Outpatient Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active AAT-App Participants will receive the active AAT-App. AAT-App: Participants will receive the active AAT-App on their smartphone, which includes ApBM training, and prompted to engage with the app during the 28-day intervention period. 0 None 0 39 0 39 View
Minimal AAT-App Participants will receive the minimal version of AAT-App. Minimal AAT-App: Participants will receive the minimal version of AAT-App, which does not include ApBM training, on their smartphone and prompted to engage with the app during the 28-day intervention period. 0 None 0 40 0 40 View
Serious Events(If Any):
Other Events(If Any):