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 @ 12:44 AM
Ignite Modification Date: 2025-12-25 @ 10:57 PM
NCT ID: NCT01659567
Description: None
Frequency Threshold: 0
Time Frame: Baseline up to 96 weeks
Study: NCT01659567
Study Brief: A Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Participants With Hepatitis C
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pegylated Interferon Alfa-2a and Ribavirin Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks. None None 17 516 256 516 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia fourth degree NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tachyarrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia fourth degree NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia fourth degree NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Rectal bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Lingual bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Agitation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Flushing NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Alopecia/hair loss NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Itching/pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Anal itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Bilirubinemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thyrotoxicosis second degree NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia second degree NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia third degree NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia second degree NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia third degree NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia second degree NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia third degree NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Liver enzymes incresed (ALT, AST other) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
ST elevation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Paresthesia (numbness in hands) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hemorrhoid varicose veins NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hyperemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Herpes rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Left nostril furuncle NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Sweating - general NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Toxidermia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Sty NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle weakness in legs NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Allergic reactions NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Autoimmune thyroiditis NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Irritability NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sexual potency impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Flue-like syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sour throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Heartburn NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper/epigastric pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Meteorism (flatulence) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Adynamy NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
General weakness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Rigors NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Sweating - general NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Earache NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Pollakiuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Scalding during urination/urine scald NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Sexual potency impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Weight decrease NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperthyroidism NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Loss of appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Emotional liability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View