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 |
|---|---|---|---|---|---|---|---|---|
| Immunoadsorption/Dexamethasone/Rituximab | Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks Rituximab: 1000 mg i.v. given twice at a 2-week interval Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks Azathioprine: 2.5 mg/kg body weight daily p.o. Mycophenolate mofetil 2 g/d p.o. | None | None | 2 | 23 | 0 | 23 | View |