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 |
|---|---|---|---|---|---|---|---|---|
| IL-YANG Quadrivalent Influenza Vaccine | The QIV is included both B strain (Yamagata, Victoria). IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection. | None | None | 0 | 1194 | 0 | 1194 | View |
| IL-YANG Flu Vaccine Prefilled Syringe | This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS. IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection. | None | None | 2 | 298 | 0 | 298 | View |
| IL-YANG Trivalent Influenza Vaccine | This TIV is included the B/Victoria strain. IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection. | None | None | 1 | 299 | 0 | 299 | View |