Adverse Events Module

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 @ 2:34 AM
Ignite Modification Date: 2025-12-26 @ 1:10 AM
NCT ID: NCT03514134
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected at the beginning of the study start date until the last follow-up employment data was collected, an average of 12 months.
Study: NCT03514134
Study Brief: Modifying (Phase I) and Evaluating (Phase II) Virtual Reality Job Interview Training for Youth in Transition
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Services as Usual Study participants will be receiving their community-based or school-based services as usual that may include but is not limited to vocational skill training, daily living skill training, and social skill training. Services as Usual: Study participants will be receiving their community-based or school-based services as usual that may include but is not limited to vocational skill training, daily living skill training, and social skill training. 0 None 0 23 0 23 View
Services as Usual + Virtual Reality Job Interview Training In addition to the services as usual comparator, participants will participate in Virtual Reality Job Interview Training. Virtual Reality Job Interview Training: Students will engage in didactic training related to strategies to perform well during a job interview as well as repeated practice with a virtual hiring manager. Throughout and after completion of the virtual interviews, participants will receive feedback on their performance. Services as Usual: Study participants will be receiving their community-based or school-based services as usual that may include but is not limited to vocational skill training, daily living skill training, and social skill training. 0 None 0 48 0 48 View
Serious Events(If Any):
Other Events(If Any):