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 |
|---|---|---|---|---|---|---|---|---|
| Silastic Silicone Spacer | Silastic Silicone spacers are actively being used as the standard of care. Silastic Silicone Spacer: The Silastic Silicone Spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery. | 0 | None | 0 | 3 | 0 | 3 | View |
| Restora™ Steroid Eluting Spacer | This study arm receives the experimental treatment, a Restora™ Steroid eluting spacer. Restora™ Steroid eluting spacer: The Restora™ Steroid eluting spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery. | 0 | None | 0 | 3 | 0 | 3 | View |