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 |
|---|---|---|---|---|---|---|---|---|
| SBIRT | The SBIRT-VA manual codifies basic substance abuse screening, treatment, Motivational Interviewing and referral procedures. It is designed for providers with minimal substance abuse expertise and is easy for experienced substance abuse providers to deliver. Study sessions include identifying the Veterans' values through a card sort, the change ruler, on which the Veteran rates his/her willingness to change current behavior, listing the pros and cons of changing. SBIRT: SBIRT Therapy overview- 1. Therapist explains purpose of the therapy. 2. Inquiry about Compensation examination-ask if Veteran has questions about determination process and address concerns. 3. Discuss relationship between PTSD and substance use- long-term substance use is a form of avoidance and barrier to recovery. 4. Discuss treatment needs, administer screening, provide feedback. | 0 | None | 0 | 85 | 0 | 85 | View |
| No Additional Treatment | Veterans assigned to the control condition will not receive any study-related therapy. A Veteran who completes a Compensation examination ordinarily has no further treatment, referral, or debriefing as part of the Compensation examination. | 0 | None | 0 | 87 | 0 | 87 | View |
| Not Randomized | Veterans reporting no risky substance use at baseline. | 0 | None | 0 | 174 | 0 | 174 | View |