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 |
|---|---|---|---|---|---|---|---|---|
| Deleobuvir + Faldaprevir, Mild Renal Impairment | Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment. Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4. All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min. | None | None | 0 | 4 | 1 | 4 | View |