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 @ 12:14 AM
Ignite Modification Date: 2025-12-25 @ 10:16 PM
NCT ID: NCT02781558
Description: Safety Analysis Set
Frequency Threshold: 5
Time Frame: Up to 12 weeks plus 30 days
Study: NCT02781558
Study Brief: Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis
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 SOF/VEL 400/100 mg FDC tablet once daily for 12 weeks 0 None 4 101 24 101 View
SOF/VEL + RBV SOF/VEL 400/100 mg FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks 0 None 2 103 55 103 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Accident at work SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 20.0 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 20.0 View
Hepatic cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 20.0 View
Hepatocellular carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 20.0 View
Non-small cell lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 20.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0 View
Pharyngotonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 20.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 20.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 20.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 20.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 20.0 View