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 |
|---|---|---|---|---|---|---|---|---|
| Live Attenuated Influenza Vaccine | Participants receiving live attenuated influenza vaccine (LAIV) were initially screened per the study protocol to ensure that inclusion and exclusion criteria were complete. Participants were then invited to the vaccination arm of the study, where n=40 participants received LAIV and completed 5 study visits each over the course of 28 days. | 0 | None | 0 | 40 | 0 | 40 | View |
| Mucosal Immune Stability Cohort | In the placebo/vehicle challenge 'Mucosal immune stability' arm, a further n=8 participants attended for a single 8 hour visit at which repeat nasal samples were collected to match the LAIV arm. | 0 | None | 0 | 8 | 0 | 8 | View |