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 |
|---|---|---|---|---|---|---|---|---|
| L-Name in Young | 10 individuals age 18-35 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME. L-NAME: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging | 0 | None | 0 | 10 | 0 | 10 | View |
| Phenylephrine | 10 individuals age 18-35 will be getting an infusion of phenylephrine (primarily an alpha agonist) during 3 separate PET study days Phenylephrine: alpha agonist; 10 μg/kg/min infusion during PET study | 0 | None | 0 | 10 | 0 | 10 | View |
| L-arginine in Young | 12 individuals age 18-35 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days L-Arginine: aids in nitric oxide production | 0 | None | 0 | 12 | 0 | 12 | View |
| L-arginine in Old | 12 individuals age 60-75 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days L-Arginine: aids in nitric oxide production | 0 | None | 0 | 10 | 0 | 10 | View |
| L-NAME in Old | 10 individuals age 60-75 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME L-NAME: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging | 0 | None | 0 | 12 | 0 | 12 | View |