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 |
|---|---|---|---|---|---|---|---|---|
| Topical Lidocaine | 16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus. Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots | 0 | None | 0 | 15 | 0 | 15 | View |
| Nebuliser Solution | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes. Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer | 0 | None | 0 | 7 | 0 | 7 | View |
| Nebuliser Suspension | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes. Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer | 0 | None | 0 | 7 | 0 | 7 | View |