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 |
|---|---|---|---|---|---|---|---|---|
| SOC Alginate Dressing | SOC absorptive alginate primary dressing in conjunction with a class II multi-layer compression wrap and standard debridement SOC alginate dressing and compression therapy: Alginate dressing is an absorbent wound care product that contains sodium and calcium fibers to absorb fluids and promote healing | 1 | None | 0 | 1 | 0 | 1 | View |
| AmnioExCel Dressing | AmnioExCel dressing in conjunction with a class II multilayer compression wrap and standard debridement AmnioExCel dressing and compression therapy: Use of a dehydrated human amnion membrane as a biologic adjunct to the standard of care in patients with venous leg ulcers | 1 | None | 0 | 1 | 1 | 1 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| contralateral leg venous ulcer infection | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |