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 |
|---|---|---|---|---|---|---|---|---|
| Standard Care | Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC) | None | None | 0 | 128 | 5 | 128 | View |
| Lifestyle Intervention | Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy. | None | None | 0 | 129 | 4 | 129 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Preterm Delivery | SYSTEMATIC_ASSESSMENT | General disorders | Preterm Delivery | View |