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 |
|---|---|---|---|---|---|---|---|---|
| LASIK Followed by Cross-linking (Continuous Wave) | Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA. riboflavin ophthalmic solution, 0% dextran UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA) Laser-assisted in situ keratomileusis | None | None | 0 | 0 | 0 | 0 | View |
| LASIK Followed by Cross-linking (Pulsed) | Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off. riboflavin ophthalmic solution, 0% dextran UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off) Laser-assisted in situ keratomileusis | None | None | 0 | 2 | 2 | 2 | View |
| LASIK Only | Eyes assigned to this arm will receive standard LASIK with no cross-linking. Laser-assisted in situ keratomileusis | None | None | 0 | 0 | 2 | 2 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vision blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Foreign body sensation in eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Photophobia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Conjunctival hyperaemia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Eye irritation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Corneal flap complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |