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 |
|---|---|---|---|---|---|---|---|---|
| 4 Week Disulfiram | Patients in this group receive disulfiram for 4 weeks followed by placebo capsules for 4 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg during week 3, and 500 mg daily during week 4. Placebo capsules are given during weeks 5-8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects. Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks . | 0 | None | 1 | 4 | 1 | 4 | View |
| 8 Week Disulfiram | Patients in this group receive disulfiram for 8 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg for week 3, and 500 mg daily for week 4 to week 8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects. Disulfiram: Patients will receive disulfiram for 8 weeks . | 0 | None | 1 | 5 | 5 | 5 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Mild-moderately elevated liver function tests | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Mildly elevated serum creatinine | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Moderate headache | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Moderate to severe sore throat/throat hoarseness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Moderate to severe hypersomnia/sleepiness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Moderate tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Moderate shooting pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Moderate photosensitivity | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Moderate dizziness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Moderate temperature fluctuations | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Moderate neuromotor weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |