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 |
|---|---|---|---|---|---|---|---|---|
| Dexamethasone Ophthalmic Insert 0.4 mg | Dexamethasone ophthalmic insert 0.4 mg Dexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert | 0 | None | 0 | 20 | 3 | 20 | View |
| Topical Prednisolone Acetate Ophthalmic Drops | Topical prednisolone acetate ophthalmic drops per standard of care: Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue. | 0 | None | 0 | 20 | 0 | 20 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Intraocular pressure elevation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |