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 |
|---|---|---|---|---|---|---|---|---|
| Healthy Participants | Healthy participants were invited to donate a blood sample for biomarker measurement on day one. They were also requested to undergo measurements of intestinal permeability by taking a 100 milliliter (mL) solution of lactulose (5 gram \[g\]) and mannitol (2g) along with 3 capsules (2g) of sucralose on days 1, 8 and 15 followed by a 24 hour urine collection. | 0 | None | 0 | 15 | 5 | 15 | View |
| Thermally Injured Participants | Participants were invited to undergo measurements of intestinal permeability by taking a 100 mL solution of lactulose (5 g) and mannitol (2g) along with 3 capsules (2g) of sucralose on days 1,3,5,7,9,11 and 13. | 2 | None | 0 | 3 | 0 | 3 | View |