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 |
|---|---|---|---|---|---|---|---|---|
| CyclASol 0.05% Ophthalmic Solution | Blinded treatment arm. Cyclosporine A solution (0.05%) in vehicle. Topical ocular eye drops. 1 drop in each eye, twice daily. | 0 | None | 2 | 51 | 5 | 51 | View |
| CyclASol 0.1% Ophthalmic Solution | Blinded treatment arm. Cyclosporine A solution (0.1%) in vehicle. Topical ocular eye drops. 1 drop in each eye, twice daily. | 0 | None | 0 | 51 | 4 | 51 | View |
| Placebo Ophthalmic Solution | Blinded treatment arm. Vehicle only Topical ocular eye drops. 1 drop in each eye, twice daily. | 0 | None | 0 | 52 | 4 | 52 | View |
| Restasis | Active comparator, open label arm . Cyclosporine A 0.05% ophthalmic emulsion topical ocular eye drops. 1 drop in each eye, twice daily. | 0 | None | 1 | 53 | 4 | 53 | View |