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 |
|---|---|---|---|---|---|---|---|---|
| Enhanced Usual Care | ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months ADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook | 6 | None | 0 | 394 | 0 | 394 | View |
| Intervention | ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months ACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide | 3 | None | 0 | 362 | 0 | 362 | View |