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 |
|---|---|---|---|---|---|---|---|---|
| Custom Samfilcon B Contact Lenses | Participants will wear Bausch + Lomb investigational custom samfilcon B contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store their worn study lenses in a lens case filled with Biotrue multi-purpose solution (MPS). Custom Samfilcon B Contact Lenses: Contact lens ReNu MultiPlus Lubricating and Rewetting Drops: For use as needed during the study. Biotrue Multi-Purpose Solution: For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study. | 0 | None | 0 | 56 | 0 | 56 | View |
| Alden Optical HP Sphere Contact Lenses | Participants will wear Alden Optical HP Sphere contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store worn study lenses in a lens case filled with Biotrue MPS. Alden Optical HP Sphere Contact Lens: Hioxifilcon D, 54% water, Alden Optical HP Sphere lens ReNu MultiPlus Lubricating and Rewetting Drops: For use as needed during the study. Biotrue Multi-Purpose Solution: For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study. | 0 | None | 0 | 28 | 0 | 28 | View |