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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| TeamTRACS (Team Training in Roles, Awareness, Communication, and Support) | CACs randomized to the intervention condition (n = 4) will participate in TeamTRACS. CACs will receive an implementation guide to assist in preparing for and maximizing the impact of training. TeamTRACS: TeamTRACS is a team training intervention adapted from TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety), a widely used evidence-based team training developed by the Agency for Healthcare Research and Quality. TeamTRACS targets knowledge, skills, and attitudes related to team member roles, shared awareness, communication, mutual support, and goal-setting. TeamTRACS is structured, easy to use, flexible in length and intensity, and requires few resources. It incorporates didactic instruction, discussion, and interactive activities and can be delivered virtually or in-person. | 0 | None | 0 | 117 | 0 | 117 | View |
| Waitlist Comparison | CACs randomized to the waitlist comparison (n = 2) will participate in TeamTRACS approximately 4 months after CACs in the intervention condition. | 0 | None | 0 | 55 | 0 | 55 | View |