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 |
|---|---|---|---|---|---|---|---|---|
| PRK Correction With iDesign System and STAR S4 IR Laser | Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser | 0 | None | 10 | 167 | 0 | 167 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Retinal Detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Anterior Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Corneal Abrasions | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Corneal Infiltrate | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Corneal Haze | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Corneal Erosion | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |