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 |
|---|---|---|---|---|---|---|---|---|
| Emotional Disclosure and Brain Education ("Educational Interview") | Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain. Emotional Disclosure and Brain Education: Patients are interviewed about a number of aspects of their lives (stress, other illnesses, personality, adverse childhood experiences), and these are explored as part of education of the brain's role in their pain. | 0 | None | 0 | 29 | 0 | 29 | View |
| Emotional Disclosure Only ("Psychosocial Interview") | Patients are interviewed about stress, psychosocial risk factors, and other emotional issues, but with no feedback or brain-related education. Emotional Disclosure Only: Patients are interviewed about a number of aspects of their lives, but without brain education | 0 | None | 0 | 34 | 0 | 34 | View |
| Pain Information Control ("Standard Interview") | Patients are interviewed about their pain history and experience. Pain Information Control: Patients are interviewed about their pain history and other basic, non-disclosure information about their health. | 0 | None | 0 | 31 | 0 | 31 | View |