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 |
|---|---|---|---|---|---|---|---|---|
| CYP2D6 Rapid Metabolizer (Granisetron) | Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment Granisetron: Rapid metabolizer received 1mg IV Granisetron | 0 | None | 0 | 2 | 0 | 2 | View |
| CYP2D6 Normal Metabolizer (Ondansetron) | Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV | 0 | None | 0 | 90 | 0 | 90 | View |