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: 2025-12-25 @ 4:06 AM
Ignite Modification Date: 2025-12-26 @ 3:02 AM
NCT ID: NCT01447420
Description: Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Frequency Threshold: 5
Time Frame: Up to Week 72
Study: NCT01447420
Study Brief: A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Peginterferon Alfa-2a Plus Ribavirin Eligible participants were administered peginterferon alfa-2a, 180 mcg SC weekly, 48 weeks and Ribavirin 1000 mg per day for \< 75 kg and 1200 mg per day for \>= 75 kg, orally daily, 48 weeks. None None 6 129 125 129 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Optic ischaemic neuropathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Retinal vascular disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Perianal erythema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Anxiety disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Dizziness SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Upper abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Aphthous stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Chills SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View