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 |
|---|---|---|---|---|---|---|---|---|
| Viral Conjunctivitis Treatment | Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid 0.01% Hypochlorous acid: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device) | 0 | None | 0 | 6 | 1 | 6 | View |
| Viral Conjunctivitis Placebo | Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline Placebo: Placebo to be used four times a day to the affected eye for 2 weeks | 0 | None | 0 | 5 | 0 | 5 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| HSV Keratitis | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |