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 |
|---|---|---|---|---|---|---|---|---|
| Varenicline | Varenicline: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period. | 0 | None | 0 | 3 | 1 | 3 | View |
| Placebo | Placebo: Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period. | 0 | None | 1 | 2 | 0 | 2 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| voluntary psychiatric hospitalization | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |