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 |
|---|---|---|---|---|---|---|---|---|
| Standard of Care | Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks. | None | None | 0 | 50 | 50 | 50 | View |
| Triple Therapy | Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks. | None | None | 0 | 50 | 47 | 50 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fever | None | General disorders | None | View |
| Fatigue | None | General disorders | None | View |
| dyspepsia | None | Gastrointestinal disorders | None | View |
| anorexia | None | Gastrointestinal disorders | None | View |
| constipation | None | Gastrointestinal disorders | None | View |
| diarrhea | None | Gastrointestinal disorders | None | View |
| musculoskeletal pains | None | Musculoskeletal and connective tissue disorders | None | View |
| itching | None | Skin and subcutaneous tissue disorders | None | View |
| rash | None | Skin and subcutaneous tissue disorders | None | View |
| depression | None | Psychiatric disorders | None | View |
| Shortness of breath | None | Respiratory, thoracic and mediastinal disorders | None | View |
| cough | None | Respiratory, thoracic and mediastinal disorders | None | View |
| insomnia | None | Psychiatric disorders | None | View |
| headache | None | General disorders | None | View |
| Neutropenia (<1000/ml) | None | Blood and lymphatic system disorders | None | View |
| Anemia (Hgb <10g/dl) | None | Blood and lymphatic system disorders | None | View |
| facial palsy | None | Nervous system disorders | None | View |