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 |
|---|---|---|---|---|---|---|---|---|
| Electronic Cigarette | The participants will use a JUUL e-cigarette device with a JUUL e-liquid pod in a standardized vaping session consisting of one 3.5 second puff every 30 seconds for a total of 10 puffs. This will be followed by a 2.5 hour abstinence period. They will then use the JUUL e-cigarette as they wish (ad-lib use) for 4 hours. | 0 | None | 0 | 16 | 2 | 16 | View |
| Tobacco Cigarette | The participants will use a tobacco cigarette in a standardized smoking session consisting of one 3.5 second puff every 30 seconds for a total of 10 puffs. This will be followed by a 2.5 hour abstinence period. They will then use the tobacco cigarette as they wish (ad-lib use) for 4 hours. | 0 | None | 0 | 16 | 1 | 16 | View |