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 |
|---|---|---|---|---|---|---|---|---|
| Lutein, Zeaxanthin and Mesozeaxanthin | Patients will be asked to consume 1 pill daily with a meal, for six months. The pills will contain 22 mg total of the carotenoids lutein (10 mg), zeaxanthin (2 mg), and mesozeaxanthin (10 mg). Lutein, zeaxanthin and mesozeaxanthin: The intervention will involve supplementation with the macular carotenoids (1 pill daily with a meal containing lutein, zeaxanthin, mesozeaxanthin) for six months, to determine the effects on visual performance in glaucoma patients. | 0 | None | 0 | 3 | 0 | 3 | View |
| Placebo | Patients will be asked to consume 1 pill daily with a meal, for six months. The pills will contain only sunflower oil (placebo). Placebo: This intervention involves an inert pill (1 pill daily with a meal) that contains only sunflower oil, for six months. | 0 | None | 0 | 5 | 0 | 5 | View |