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 |
|---|---|---|---|---|---|---|---|---|
| Buffered 2% Lidocaine With 1:100,000 Epinephrine | Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution) Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution: Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic 2% lidocaine with 1:100,000 epinephrine: Septodont's standard formulation of 2% lidocaine with epinephrine | 0 | None | 0 | 20 | 0 | 20 | View |
| Unbuffered 2% Lidocaine With 1:100,000 Epinephrine | Standard local anesthetic 2% lidocaine with 1:100,000 epinephrine: Septodont's standard formulation of 2% lidocaine with epinephrine | 0 | None | 0 | 20 | 0 | 20 | View |