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 |
|---|---|---|---|---|---|---|---|---|
| Normal-renal Function | Patients with normal-renal function defined by 90 ≤ GFR ≤ 130 mL/min/1.73m2 in women or 140 mL/min/1.73m2 in men | 0 | None | 1 | 10 | 2 | 10 | View |
| Glomerular Hyperfiltration | Patients with glomerular renal hyperfiltration defined by GFR \> 130 mL/min/1.73m2 in women and GFR \> 140 mL/min/1.73m2 in men. | 0 | None | 0 | 12 | 0 | 12 | View |
| Moderate Renal Failure | Patients with moderate renal failure defined by 30 ≤ GFR ≤ 60 mL/min/1.73m2 | 0 | None | 1 | 5 | 0 | 5 | View |