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 |
|---|---|---|---|---|---|---|---|---|
| Cinnamaldehyde | Participants who inhaled cinnamaldehyde e-liquid in either Period 1 or Period 2 as per randomization schedule. Cinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency). | 0 | None | 0 | 4 | 0 | 4 | View |
| PG/VG | Participants who inhaled Propylene Glycol/Vegetable Glycerin (PG/VG) e-liquid in either Period 1 or Period 2 as per randomization schedule. PG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency). | 0 | None | 0 | 5 | 0 | 5 | View |
| Healthy Controls | Participants will only undergo the baseline testing and thus serve as a non-exposed/non-vaping control group. | 0 | None | 0 | 4 | 0 | 4 | View |