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 |
|---|---|---|---|---|---|---|---|---|
| Folic Acid Group | 20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months. folic acid: drugs used to delay progression of chronic kidney disease | 0 | None | 0 | 20 | 0 | 20 | View |
| Pentoxifylline Group | 20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months. Pentoxifylline 400 MG: drugs used to delay progression of chronic kidney disease | 0 | None | 0 | 20 | 0 | 20 | View |
| Folic Acid and Pentoxifylline Group | 20 patients will receive combination therapy of folic acid5 mg per day and pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months combination of Pentoxifylline 400 MG and Folic Acid: drugs used to delay progression of chronic kidney disease | 0 | None | 0 | 20 | 0 | 20 | View |
| Control Group | 20 patients will receive their standard therapy only. | 0 | None | 0 | 20 | 0 | 20 | View |