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 |
|---|---|---|---|---|---|---|---|---|
| Tobacco Smokers During a Quit Attempt | Abstinent tobacco smokers receiving a MRI and a PET scan with the alpha7-nAChR radiotracer \[18F\]-ASEM to assess alpha-7-nicotinic acetylcholine receptor availability and are incentivized for successfully abstaining from cigarettes for up to 8 days. \[F18\]-ASEM (3-(1,4-diazabicyclo\[3.2.2\]nonan-4-yl)-6-\[18F\]fluorodibenzo\[b,d\]thiophene 5,5-dioxide): Brain imaging of alpha-7 nicotinic acetylcholine receptors Contingency Management: Incentive payments contingent upon provision of samples that meet criterion levels of exhaled carbon oxide and urinary cotinine at study visits | 0 | None | 0 | 15 | 0 | 15 | View |