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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Control | The control group will conduct usual public health practice. | 0 | None | 0 | 0 | 0 | 0 | View |
| Intervention | Participating local health departments will help develop and choose several dissemination activities they prefer for their local health department to receive. Dissemination activities may include multi-day in-person training workshops, electronic information exchange modalities, remote technical assistance, and information on ways to enhance organizational climates favorable to evidence-based diabetes and chronic disease prevention and control. Dissemination of public health knowledge: Participating local health departments will help develop and choose dissemination strategies they prefer for their staff working in and supporting diabetes and chronic disease prevention and control to receive. Dissemination strategies may include multi-day in-person training workshops, electronic information exchange modalities, remote technical assistance, and information on ways to enhance organizational climates favorable to evidence-based diabetes prevention and control. | 0 | None | 0 | 0 | 0 | 0 | View |