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 |
|---|---|---|---|---|---|---|---|---|
| Shaping Intervention for Hard-to-treat Smokers | Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule. | None | None | 0 | 36 | 0 | 36 | View |
| Fixed Criterion Intervention for Hard-to-treat Smokers | fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs \< 3 ppm. | None | None | 0 | 38 | 0 | 38 | View |
| Non Contingent Incentives Available to Hard to Treat Smokers | Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis. | None | None | 0 | 18 | 0 | 18 | View |
| Ascending Incentives Values Used in Smokers With Early Success | Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery. | None | None | 0 | 60 | 0 | 60 | View |
| Fixed Value Incentives Are Used in Smokers With Early Success | fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value | None | None | 0 | 58 | 0 | 58 | View |
| Non Contingent Incentives Are Available to Smokers With Early | Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis. | None | None | 0 | 29 | 0 | 29 | View |