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 |
|---|---|---|---|---|---|---|---|---|
| Delayed | Intervention: Raindrop Near Vision Inlay In the delayed approach, the corneal pocket is created and dissected but the corneal inlay is not implanted. After one to three months, the corneal inlay is implanted on a second surgical day. Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems. | 0 | None | 0 | 0 | 0 | 0 | View |
| Non-Delayed | Intervention: Raindrop Near Vision Inlay In the non-delayed approach, the corneal pocket is created and inlay implanted on the same surgical day. Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems. | 0 | None | 0 | 0 | 0 | 0 | View |