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 |
|---|---|---|---|---|---|---|---|---|
| Peginterferon and Ribavirin Arm | Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks. | None | None | 0 | 21 | 2 | 21 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| symptomatic anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |