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 |
|---|---|---|---|---|---|---|---|---|
| IV Lidocaine | IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes | None | None | 0 | 18 | 0 | 18 | View |
| IV Diphenhydramine | IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes | None | None | 0 | 19 | 0 | 19 | View |
| Washout Period After IV Lidocaine | Washout period after IV Lidocaine before IV diphenhydramine | None | None | 0 | 10 | 0 | 10 | View |
| Washout Period After IV Diphenhydramine | Washout period after IV diphenhydramine before IV Lidocaine | None | None | 0 | 8 | 0 | 8 | View |