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 |
|---|---|---|---|---|---|---|---|---|
| TENS Unit | This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control. Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation. | None | None | 0 | 22 | 1 | 22 | View |
| Control Arm | This arm will have standard care for their post operative pain control. | None | None | 0 | 20 | 0 | 20 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| TENS interfered with cardiac monitor | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |