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 |
|---|---|---|---|---|---|---|---|---|
| Acupuncture | This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture. Acupuncture for pain management: A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room. Usual care for pain management: Patient will receive usual care for pain management. | 1 | None | 1 | 83 | 0 | 83 | View |
| Usual Care | This arm will receive usual care for pain management. Usual care for pain management: Patient will receive usual care for pain management. | 0 | None | 1 | 82 | 0 | 82 | View |
| ED Staff/Providers | ED Staff and Providers were asked complete 2 questions about their perceptions of acupuncture in the ED. If the ED staff or providers had direct contact with the ACUITY study in their ED, then they were asked to complete 2 additional questions inquiring about how ACUITY may have impacted the ED. | 0 | None | 0 | 125 | 0 | 125 | View |