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 |
|---|---|---|---|---|---|---|---|---|
| 0.3mm XPF Cap | Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions. 0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material. | 0 | None | 0 | 74 | 0 | 74 | View |
| 0.5mm XPF Cap | Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. 0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material. | 0 | None | 0 | 64 | 0 | 64 | View |
| Standard Cap | Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. | 0 | None | 0 | 59 | 0 | 59 | View |