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 |
|---|---|---|---|---|---|---|---|---|
| Skin Tag Removal Initial Visit Plus Follow-up | Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device. Digiclamp (Skin tag removal initial plus follow-up): Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp. | 0 | None | 0 | 20 | 0 | 20 | View |