Adverse Events Module

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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: 2025-12-25 @ 1:43 AM
Ignite Modification Date: 2025-12-26 @ 12:00 AM
NCT ID: NCT02185794
Description: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
Frequency Threshold: 5
Time Frame: Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
Study: NCT02185794
Study Brief: Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus 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
Voxilaprevir 300 mg Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2. 0 None 0 15 2 15 View
Voxilaprevir 100 mg + SOF/VEL 400/100 mg Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. This arm was part of cohort 10. 0 None 0 16 2 16 View
Placebo Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, and 3. 0 None 0 8 2 8 View
Voxilaprevir 50 mg Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2. 0 None 0 14 2 14 View
Voxilaprevir 100 mg Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6. 0 None 0 30 2 30 View
Voxilaprevir 100 mg Fed Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6. 0 None 1 6 1 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View