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 |
|---|---|---|---|---|---|---|---|---|
| Bupropion SR (Sustained Release) | Group receiving bupropion SR medication Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days \- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment | None | None | 2 | 5 | 2 | 5 | View |
| Placebo | Group receiving placebo -Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment | None | None | 0 | 6 | 3 | 6 | View |