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 |
|---|---|---|---|---|---|---|---|---|
| E-Cigarette Switching (EC) | Participants will be asked to completely switch from cigarettes to e-cigarettes. They will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. E-cigarette: Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt. | 0 | None | 0 | 30 | 0 | 30 | View |
| E-cigarette Switching (EC) + Financial Incentives | Participants will be asked to completely switch from cigarettes to e-cigarettes, and they will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. Participants will also receive weekly financial incentives for biochemically-verified cigarette abstinence during the first 4 weeks following the switch date. Financial incentives + E-cigarette: Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt. | 0 | None | 0 | 30 | 0 | 30 | View |