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 |
|---|---|---|---|---|---|---|---|---|
| Pressure Garment on Burn Wound | Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17-24 mm Hg to the normal/high compression zone and \<5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing. | None | None | 0 | 54 | 0 | 54 | View |