Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 7:44 PM
Ignite Modification Date: 2025-12-25 @ 5:22 PM
NCT ID: NCT02300103
Description: Safety Analysis Set
Frequency Threshold: 5
Time Frame: Treatment Phase: Up to 24 weeks with an onset date on or after the study drug start date plus 30 days
Study: NCT02300103
Study Brief: Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SOF/VEL+RBV SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks 0 None 1 69 55 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Haemolytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system 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
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View