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 |
|---|---|---|---|---|---|---|---|---|
| Quitline Treatment as Usual (TAU) | Quitline services provided by participating state quitlines Quitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content). | 0 | None | 0 | 73 | 0 | 73 | View |
| Quitline TAU Plus Remote CO Monitoring | Quitline service plus daily CO monitoring via a smartphone app Quitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content). Remote Carbon Monoxide (CO) Monitoring: Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor. | 0 | None | 0 | 76 | 0 | 76 | View |
| Quitline TAU Plus Incentivized Remote CO Monitoring | Quitline TAU plus remote CO monitoring with small monetary incentives Quitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content). Incentivized Remote CO Monitoring: Incentivized remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor and delivers small monetary incentives for each use of the CO monitor. | 0 | None | 0 | 80 | 0 | 80 | View |