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 |
|---|---|---|---|---|---|---|---|---|
| MSK-Tracker (Before) | Usual Care in clinic consultations | 0 | None | 0 | 141 | 0 | 141 | View |
| MSK-Tracker (After) | Use of the MSK-Tracker in clinic consultations MSK-Tracker: The intervention is not a treatment, but involves patients and clinicians engaging with the MSK-Tracker software which will facilitate a new care planning approach with the following distinct components: * Pre-clinic preparation. * Clinic dashboard. * Summary action plan. * Personal goal setting. * Follow-up and monitoring. | 0 | None | 0 | 132 | 0 | 132 | View |