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 |
|---|---|---|---|---|---|---|---|---|
| Celecoxib | •Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15, oral capecitabine twice daily on days 1-14, and oral celecoxib twice daily on days 1-21. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV once daily on day 1, oral celecoxib twice daily on days 1-14, and filgrastim subcutaneously once daily on days 3-10. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Celecoxib is stopped one week prior to surgery. •Surgery: standard of care | None | None | 1 | 3 | 3 | 3 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenic Fever | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Weight Loss | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Elevated Liver Enzymes | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Lacrimal Stenosis | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Intractable nausea and vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Neutropenic fever | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Obstruction nasolacrimal duct | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |