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 |
|---|---|---|---|---|---|---|---|---|
| Intervention Arm | Primary care text message outreach to unvaccinated patients and resources to support PCPs Primary care text message outreach to unvaccinated patients and resources to support PCPs: Patients: Eligible patients will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination. Providers: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase"). | 0 | None | 0 | 0 | 0 | 0 | View |
| Control Arm | Patients will receive usual care | 0 | None | 0 | 0 | 0 | 0 | View |