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 |
|---|---|---|---|---|---|---|---|---|
| Gadobutrol (Gadavist, BAY 86-4875) | Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection. | None | None | 0 | 315 | 14 | 315 | View |