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 |
|---|---|---|---|---|---|---|---|---|
| Toolkit Plus Coaching | Clinics in this arm are given access to an online care coordination toolkit plus quality improvement support from a distance-based coach. Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes. Distance-based coaching: The distance-based coach supports included clinics in carrying out a quality improvement project focused on care coordination, either using the online toolkit or other resources determined by the clinic. | 0 | None | 0 | 0 | 0 | 0 | View |
| Toolkit Only | Clinics in this arm are given access to an online care coordination toolkit. Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes. | 0 | None | 0 | 0 | 0 | 0 | View |