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 |
|---|---|---|---|---|---|---|---|---|
| Restasis and Dextenza | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids. Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye | 0 | None | 0 | 10 | 2 | 10 | View |
| Restasis and Lotemax | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes. Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation Loteprednol Etabonate: Used to treat inflammation of the eye | 0 | None | 0 | 10 | 0 | 10 | View |
| Restasis | 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes Cyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation | 0 | None | 0 | 10 | 0 | 10 | View |