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: 2025-12-25 @ 12:27 AM
Ignite Modification Date: 2025-12-25 @ 10:32 PM
NCT ID: NCT04841967
Description: At the conclusion of the 4-week and 12-week data collection time points, participants were asked via an open-ended survey question about their reaction to participating in the study to assess for adverse events. For parents that reported disclosure to their children at the 4-week or 12-week time points, parent participants were asked about their child(ren)'s reaction(s) to the disclosure.
Frequency Threshold: 0
Time Frame: Parents who participated in the pilot, RCT were assessed about adverse events at the 4-week and 12-week post-test data collection time points. The overall implementation of the pilot, RCT was from recruitment of our first parent participant into the pilot, RCT on July 26, 2021 through the 12-week post-test time point, which was September 30, 2022 when data collection for the pilot, RCT was completed.
Study: NCT04841967
Study Brief: Feasibility Trial of the TELL Tool 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
eBook Attention-Control Parents in the eBook attention-control group will complete one interactive, multimedia and multicomponent program that contains information about good parenting principles and is administered digitally. It will take parents about 60 minutes to complete the eBook attention control. eBook Attention Control: A 60-minute session with good parenting principles delivered digitally to parents at their homes or other private, quiet location. 0 None 0 34 0 34 View
TELL Tool Group Parents in the TELL Tool group will complete a decision support aid that has four interactive, multimedia and multicomponent modules that will be administered digitally. It will take parents about 60 minutes to complete the TELL Tool. TELL Tool Intervention: A 60-minute session with decision support information delivered digitally to parents at their homes or other private, quiet location. 0 None 0 41 0 41 View
Serious Events(If Any):
Other Events(If Any):