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 |
|---|---|---|---|---|---|---|---|---|
| AUD DBS | This is a single arm study. Participants will undergo baseline medical and psychiatric assessments, cognitive and behavioral testing, and positron emission tomography (PET) imaging. One to two weeks later, participants will undergo neurosurgical implantation of DBS electrodes in the limbic pallidum and a neurostimulator. Four weeks after DBS system implantation, the DBS system will be turned ON and the stimulation parameters optimized. Participants will be followed biweekly then monthly for repeat comprehensive assessments. | 1 | None | 1 | 2 | 1 | 2 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Intracranial hemorrhage during surgery | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| surgical wound pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |