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 |
|---|---|---|---|---|---|---|---|---|
| Cigarette | At the first visit, all participants used their usual brand of cigarette. Participants completed a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with cigarettes. | 0 | None | 0 | 22 | 0 | 22 | View |
| E-Cigarette | At the second and third visits, participants were randomly assigned either e-cigarette or heat not burn. All participants completed a visit for each product but the order was random. Participants completed a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with the e-cigarette. | 0 | None | 0 | 22 | 0 | 22 | View |
| Heat Not Burn | At the second and third visits, participants were randomly assigned either e-cigarette or heat not burn. All participants completed a visit for each product but the order was random. Participants completed a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with heat-not-burn. | 0 | None | 0 | 22 | 0 | 22 | View |