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 |
|---|---|---|---|---|---|---|---|---|
| Usual Care | Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. | None | None | 0 | 244 | 0 | 244 | View |
| SBIRT | Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk. | None | None | 0 | 228 | 0 | 228 | View |