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 |
|---|---|---|---|---|---|---|---|---|
| Control (AUD-) | -Without Alcohol Use Disorder and without HCV Neuropsychological assessment: Clinical research staff will complete a standardized neuropsychiatric study visit protocol with eligible participants who provide informed consent. The protocol will be conducted twice for each participant (baseline and 6 months later). Neuroimaging: Subjects, well characterized with respect to their substance use, will be evaluated with fMRI tasks, rsMRI, high resolution anatomical MRI, standard DWI and high angular resolution diffusion imaging (HARDI) at baseline and 6 months later. | 0 | None | 0 | 27 | 0 | 27 | View |
| Alcohol Use Disorder (AUD+) | -With Alcohol Use Disorder and without HCV Neuropsychological assessment: Clinical research staff will complete a standardized neuropsychiatric study visit protocol with eligible participants who provide informed consent. The protocol will be conducted twice for each participant (baseline and 6 months later). Neuroimaging: Subjects, well characterized with respect to their substance use, will be evaluated with fMRI tasks, rsMRI, high resolution anatomical MRI, standard DWI and high angular resolution diffusion imaging (HARDI) at baseline and 6 months later. | 0 | None | 0 | 14 | 0 | 14 | View |
| HCVc | -Adults treated for HCV Neuropsychological assessment: Clinical research staff will complete a standardized neuropsychiatric study visit protocol with eligible participants who provide informed consent. The protocol will be conducted twice for each participant (baseline and 6 months later). Neuroimaging: Subjects, well characterized with respect to their substance use, will be evaluated with fMRI tasks, rsMRI, high resolution anatomical MRI, standard DWI and high angular resolution diffusion imaging (HARDI) at baseline and 6 months later. | 0 | None | 0 | 5 | 0 | 5 | View |