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 |
|---|---|---|---|---|---|---|---|---|
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis | None | None | 0 | 33 | 22 | 33 | View |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis | None | None | 0 | 30 | 14 | 30 | View |
| VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis | None | None | 0 | 36 | 25 | 36 | View |
| VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis | None | None | 1 | 29 | 23 | 29 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Increased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Chromaturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.1) | View |