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 @ 5:01 AM
Ignite Modification Date: 2025-12-26 @ 4:02 AM
NCT ID: NCT00353418
Description: The Safety population included all patients randomized who received at least one dose of the study medication and had at least one postbaseline safety assessment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 274 patients.
Frequency Threshold: 5
Time Frame: None
Study: NCT00353418
Study Brief: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Genotype 1 and Human Immunodeficiency Virus-1 (HIV-1) Co-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
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg None None None 21 135 132 135 View
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg None None None 46 274 264 274 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchitis None Infections and infestations None View
Cellulitis None Infections and infestations None View
Pneumonia None Infections and infestations None View
Pneumonia Pneumococcal None Infections and infestations None View
Hepatic Neoplasm Malignant None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung Adenocarcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Brain Stem Ischaemia None Nervous system disorders None View
Convulsion None Nervous system disorders None View
Optic Neuritis None Nervous system disorders None View
Cholecystitis Acute None Hepatobiliary disorders None View
Cholelithiasis None Hepatobiliary disorders None View
Epididymitis None Reproductive system and breast disorders None View
Prostatitis None Reproductive system and breast disorders None View
Retinal Detachment None Eye disorders None View
Pyrexia None General disorders None View
Orthostatic Hypotension None Vascular disorders None View
Staphylococcal Abscess None Infections and infestations None View
Urinary Tract Infection None Infections and infestations None View
Anal Abscess None Infections and infestations None View
Bursitis Infective None Infections and infestations None View
Carbuncle None Infections and infestations None View
Gangrene None Infections and infestations None View
Gastroenteritis None Infections and infestations None View
Gastroenteritis Viral None Infections and infestations None View
Herpes Zoster None Infections and infestations None View
Infected Skin Ulcer None Infections and infestations None View
Influenza None Infections and infestations None View
Pneumococcal Bacteraemia None Infections and infestations None View
Sepsis None Infections and infestations None View
Subcutaneous Abscess None Infections and infestations None View
Subdiaphragmatic Abscess None Infections and infestations None View
Wound Infection None Infections and infestations None View
Anaemia None Blood and lymphatic system disorders None View
Haemolytic Anaemia None Blood and lymphatic system disorders None View
Thrombocytopenia None Blood and lymphatic system disorders None View
Autoimmune Thrombocytopenia None Blood and lymphatic system disorders None View
Colitis None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Oesophageal Varices Haemorrhage None Gastrointestinal disorders None View
Pancreatitis None Gastrointestinal disorders None View
Small Intestinal Obstruction None Gastrointestinal disorders None View
Depression None Psychiatric disorders None View
Completed Suicide None Psychiatric disorders None View
Substance Abuse None Psychiatric disorders None View
Suicidal Ideation None Psychiatric disorders None View
Suicide Attempt None Psychiatric disorders None View
Abnormal Loss of Weight None Metabolism and nutrition disorders None View
Dehydration None Metabolism and nutrition disorders None View
Hyperglycaemia None Metabolism and nutrition disorders None View
Hyponatraemia None Metabolism and nutrition disorders None View
Chronic Obstructive Pulmonary Disease None Respiratory, thoracic and mediastinal disorders None View
Asthma None Respiratory, thoracic and mediastinal disorders None View
Dyspnoea None Respiratory, thoracic and mediastinal disorders None View
Haemoptysis None Respiratory, thoracic and mediastinal disorders None View
Respiratory Failure None Respiratory, thoracic and mediastinal disorders None View
Acute Myocardial Infarction None Cardiac disorders None View
Atrial Fibrillation None Cardiac disorders None View
Hypertrophic Cardiomyopathy None Cardiac disorders None View
Myocardial Infarction None Cardiac disorders None View
Pericarditis None Cardiac disorders None View
Accidental Overdose None Injury, poisoning and procedural complications None View
Ankle Fracture None Injury, poisoning and procedural complications None View
Multiple Injuries None Injury, poisoning and procedural complications None View
Splenic Injury None Injury, poisoning and procedural complications None View
Pancytopenia None Blood and lymphatic system disorders None View
Vomiting None Gastrointestinal disorders None View
Abdominal Pain None Gastrointestinal disorders None View
Benign Lung Neoplasm None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation None Gastrointestinal disorders None View
Dizziness None Nervous system disorders None View
Fatigue None General disorders None View
Pyrexia None General disorders None View
Chills None General disorders None View
Irritability None General disorders None View
Pain None General disorders None View
Asthenia None General disorders None View
Malaise None General disorders None View
Nausea None Gastrointestinal disorders None View
Diarrhoea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Abdominal Pain None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Insomnia None Psychiatric disorders None View
Anxiety None Psychiatric disorders None View
Headache None Nervous system disorders None View
Upper Respiratory Tract Infection None Infections and infestations None View
Urinary Tract Infection None Infections and infestations None View
Bronchitis None Infections and infestations None View
Anaemia None Blood and lymphatic system disorders None View
Neutropenia None Blood and lymphatic system disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Muscle Spasms None Musculoskeletal and connective tissue disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Alopecia None Skin and subcutaneous tissue disorders None View
Dry Skin None Skin and subcutaneous tissue disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Night Sweats None Skin and subcutaneous tissue disorders None View
Hyperhidrosis None Skin and subcutaneous tissue disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dyspnoea None Respiratory, thoracic and mediastinal disorders None View
Epistaxis None Respiratory, thoracic and mediastinal disorders None View
Decreased Appetite None Metabolism and nutrition disorders None View
Weight Decreased None Investigations None View
Depression None Psychiatric disorders None View