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 |
|---|---|---|---|---|---|---|---|---|
| Influenza Vaccine FluShield, FluMist | Previous influenza positivity Primary Outcome Measure: 1. PET-CT Scan \[Time Frame: 4-7 days after flu vaccine\] Secondary Outcome Measures: 2. Cytokine Profiling \[Time Frame: 2-6 weeks and 10-12 months post flu vaccination FluShield, FluMist: Flu vaccine | 0 | None | 0 | 8 | 0 | 8 | View |
| Cytokine Profiling FluShield, FluMist | No previous influenza positivity Primary Outcome Measure: 1. PET-CT Scan \[Time Frame: 4-7 days after flu vaccine\] Secondary Outcome Measures: 2. Cytokine Profiling \[Time Frame: 2-6 weeks and 10-12 months post flu vaccination FluShield, FluMist: Flu vaccine | 0 | None | 0 | 8 | 0 | 8 | View |