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 |
|---|---|---|---|---|---|---|---|---|
| Saline | The saline arm will receive normal saline through the catheter as a placebo. Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used. | 0 | None | 0 | 1 | 0 | 1 | View |
| Vancomycin | The vancomycin arm will receive vancomycin solution through the catheter. Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline. | 0 | None | 0 | 1 | 0 | 1 | View |