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 |
|---|---|---|---|---|---|---|---|---|
| Antibiotic Only | 1\. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks. Augmentin: Antibiotic augmentin for 3 weeks | 0 | None | 0 | 7 | 0 | 7 | View |
| Augmentin With 6 Day Steroid | Augmentin with 6 day prednisone taper (40mg PO daily (QD) for 2 days, 20mg PO QD for 2 days, 10mg PO QD for 2 days, then stop) 6 day Prednisone: 6 day prednisone burst Augmentin: Antibiotic augmentin for 3 weeks | 0 | None | 0 | 6 | 0 | 6 | View |
| Augmentin With 21 Day Steroid | Augmentin with 21 days prednisone taper (40mg PO QD for 5 days, 30mg PO QD for 5 days, 20mg PO QD for 5 days, 10mg PO QD for 5 days, then stop. ) Augmentin: Antibiotic augmentin for 3 weeks 21 day Prednisone: 21 day prednisone burst | 0 | None | 0 | 6 | 0 | 6 | View |