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 |
|---|---|---|---|---|---|---|---|---|
| Benzocaine | benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine. Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic. Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed | None | None | 0 | 34 | 0 | 34 | View |
| Pliaglis | Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine. Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic. Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed | None | None | 0 | 30 | 0 | 30 | View |