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 |
|---|---|---|---|---|---|---|---|---|
| Group i: Concomitant | Simultaneous Vaccination (Influenza vaccine and mRNA COVID booster) at Visit 1 Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster): Influenza vaccination and mRNA COVID-19 booster will be given at Visit 1. | 0 | None | 0 | 223 | 0 | 0 | View |
| Group ii: Influenza Visit 1 | Sequential vaccination with Influenza vaccination at Visit 1 and mRNA COVID booster at Visit 2 Sequential Vaccination (Influenza vaccine then mRNA COVID booster): Influenza vaccine will be given at Visit 1 and mRNA COVID booster will be given at Visit 2. | 0 | None | 0 | 111 | 0 | 0 | View |
| Group Iii: mRNA COVID-19 Visit 1 | Sequential vaccination with mRNA COVID booster at Visit 1 and Influenza vaccination at Visit 2 Sequential Vaccination (mRNA COVID booster then Influenza vaccine): mRNA COVID booster will be given at Visit 1 and Influenza vaccine will be given at Visit 2. | 0 | None | 0 | 113 | 0 | 0 | View |