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 |
|---|---|---|---|---|---|---|---|---|
| 13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone | 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1 | None | None | 0 | 110 | 0 | 110 | View |
| Trivalent Inactivated Influenza Vaccine (TIV) Alone | Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1 | None | None | 0 | 208 | 0 | 208 | View |
| TIV and PCV13 Together | Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1 | None | None | 0 | 212 | 0 | 212 | View |