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 |
|---|---|---|---|---|---|---|---|---|
| Placebo (0.9% Normal Saline Infusion) | Infusion of 100 ml of 0.9 NS Normal Saline Placebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS | 0 | None | 0 | 54 | 0 | 54 | View |
| Intravenous Acetaminophen | Infusion of Intravenous acetaminophen (Ofirmev) Intravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight. | 0 | None | 0 | 65 | 0 | 65 | View |