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 |
|---|---|---|---|---|---|---|---|---|
| Six Hour | Placement of foley catheter and extrusion after 6 hours followed by induction. Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices | 0 | None | 0 | 101 | 0 | 101 | View |
| Twelve Hour | Placement of foley catheter and extrusion after 12 hours followed by induction. Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices | 0 | None | 0 | 99 | 1 | 99 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| incorrect foley placement | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |