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 |
|---|---|---|---|---|---|---|---|---|
| Life 4°C Media for Cornea Storage | Donor cornea is stored in the Life 4°C media prior to transplantation. Life 4°C solution for cornea storage: Donor cornea is stored in the Life 4°C media prior to transplantation. Air was reinjected in 4 eyes to treat partial graft detachment. During the 6-month follow-up period, 1 graft experienced a graft rejection episode, which responded to increased topical corticosteroid therapy. 5 eyes had intraocular pressure (IOP) elevation requiring use of glaucoma medications or reduction of topicalcorticosteroid strength or dosing frequency. 2 eyes had laser capsulotomy to treat capsular haze. 1 eye had recurrent erosions because of peripheral bullae and was treated with lamellar keratectomy, and 1 eye was diagnosed with herpes simplex virus keratitis and was treated with antiviral medication. Altogether, 14 of 27 eyes (52%) in each corneal storage solution group had a postoperative intervention (P = 1.0). | None | None | 0 | 27 | 0 | 27 | View |
| Optisol GS | Donor cornea is stored in the Optisol GS media prior to transplantation Corneal donor storage in Optisol GS media solution: Donor tissue is preserved in the Optisol media until ready for transplantation In the early postoperative period, 1 DSAEK graft in the Optisol GS group was repositioned because it fully detached. Air was reinjected in 2 eyes to treat partial graft detachment. During the 6-month follow-up period, 1 graft experienced a graft rejection episodes, which responded to increased topical corticosteroid therapy. 7 eyes had intraocular pressure (IOP) elevation requiring use of glaucoma medications or reduction of topical corticosteroid strength or dosing frequency. 2 eyes had laser capsulotomy to treat capsular haze. 1 eye had a vitreous strand associated with a capsular tear during cataract removal and was treated with laser vitreolysis.Altogether, 14 of 27 eyes (52%) in each corneal storage solution group had a postoperative intervention (P = 1.0). | None | None | 0 | 27 | 0 | 27 | View |