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 |
|---|---|---|---|---|---|---|---|---|
| SIR-Spheres Microspheres | Radioembolization treatment with SIR-Spheres microspheres is administered within 28 days of enrollment into the study. | None | None | 3 | 10 | 0 | 10 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hyperbilirubinemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| International Normalised Radio Increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Abdominal Distention | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |