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 |
|---|---|---|---|---|---|---|---|---|
| Lidocaine | 1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement | 0 | None | 0 | 50 | 0 | 50 | View |
| Buffered Lidocaine | 1% Buffered Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm Buffered lidocaine is compounded by the following process: 2.3 mLs of 8.4% sodium bicarbonate is added to a vial of 1% lidocaine Buffered Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement | 0 | None | 0 | 50 | 0 | 50 | View |
| Bacteriostatic Normal Saline | Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm Bacteriostatic Normal Saline: The medication will be administered immediately prior to receiving peripheral IV catheter placement | 0 | None | 0 | 50 | 0 | 50 | View |