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 |
|---|---|---|---|---|---|---|---|---|
| Contemporary Education Format | Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format. Intervention: Nurse education in contemporary format Nurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format | 0 | None | 0 | 6835 | 0 | 6835 | View |
| Traditional Education Format | Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over. Intervention: Nurse education in traditional format Nurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over. | 0 | None | 0 | 5941 | 0 | 5941 | View |