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 |
|---|---|---|---|---|---|---|---|---|
| Hot Compress | Patients in the hot compress arm will be shown how to apply hot compresses to the affected lid and gently massage the lid to encourage the chalazion to spontaneously drain for 5 minutes, 3x/day. Hot Compresses: Hot compresses 3x/day to eyelids | None | None | 0 | 50 | 0 | 50 | View |
| Hot Compress, Tobrex Drops, Tobrex Ointment | In addition to using hot compress, patients in the Tobramycin arm will be prescribed Tobramycin drops 3x/day and ointment to be applied before bedtime. Tobramycin Drops and Ointment: Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed. | None | None | 0 | 50 | 0 | 50 | View |
| Hot Compress, Tobradex Drops, Tobradex Ointment | In addition to using hot compress, patients in the Tobramycin/Dexamethasone arm will be prescribed Tobramycin/Dexamethasone drops 3x/day and ointment to be applied before bedtime. Tobramycin/Dexamethasone Drops and Ointment: Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed. | None | None | 0 | 50 | 0 | 50 | View |