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 |
|---|---|---|---|---|---|---|---|---|
| Glaucoma Patients | 50 Glaucoma patients recruited from Wills Eye Hospital Glaucoma Service were tested with RAPDx Pupillometer. Konan (Konan Medical USA, Irvine, CA) RAPDx (relative afferent pupillary defect) test utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light. | 0 | None | 0 | 50 | 0 | 50 | View |
| Healthy Controls | 50 Healthy controls recruited from Wills Eye Hospital Glaucoma Service staff, family and friends were tested with RAPDx Pupillometer. Konan (Konan Medical USA, Irvine, CA) RAPDx (relative afferent pupillary defect) test utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light. | 0 | None | 0 | 50 | 0 | 50 | View |