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
Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
NCT ID:
NCT02378935
Description:
Safety Analysis Set
Frequency Threshold:
5
Time Frame:
Up to 12 weeks plus 30 days
Study:
NCT02378935
Study Brief:
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection
Event Groups(If Any):
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 | 0 | None | 0 | 34 | 21 | 34 | View |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis | 0 | None | 0 | 36 | 20 | 36 | 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 | 0 | None | 2 | 33 | 18 | 33 | View |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis | 0 | None | 0 | 31 | 24 | 31 | View |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis | 0 | None | 0 | 31 | 15 | 31 | View |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis | 0 | None | 0 | 32 | 16 | 32 | View |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121 | 0 | None | 0 | 8 | 6 | 8 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Sinus headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |