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 |
|---|---|---|---|---|---|---|---|---|
| Device Acupuncture | Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session | 0 | None | 0 | 12 | 0 | 12 | View |
| Non-pain Related Video Health Education | The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group. Non-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion. | 0 | None | 0 | 15 | 0 | 15 | View |