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 |
|---|---|---|---|---|---|---|---|---|
| 13-35 Months: Acute | Children 13-35 months of age presenting with natural influenza infection Natural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age | 0 | None | 0 | 19 | 0 | 19 | View |
| 3-5 Years: Vaccinated | Children 3-5 years of age vaccinated with seasonal IIV Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age | 0 | None | 0 | 18 | 0 | 18 | View |
| 3-5 Years: Acute | Children 3-5 years of age presenting with natural influenza infection Natural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age | 0 | None | 0 | 12 | 0 | 12 | View |
| 6-8 Years: Vaccinated | Children 6-8 years of age vaccinated with seasonal IIV Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age | 0 | None | 0 | 23 | 0 | 23 | View |
| 6-8 Years: Acute | Children 6-8 years of age presenting with natural influenza infection Natural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age | 0 | None | 0 | 9 | 0 | 9 | View |
| 6-12 Months: Vaccinated | Children 6 - 12 months of age vaccinated with seasonal IIV Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age | 0 | None | 0 | 13 | 0 | 13 | View |
| 3-12 Months: Acute | Children 3-12 months of age presenting with natural influenza infection Natural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age | 0 | None | 0 | 8 | 0 | 8 | View |
| 13-35 Months: Vaccinated | Children 13-35 months of age vaccinated with seasonal IIV Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age | 0 | None | 0 | 30 | 0 | 30 | View |