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: 2025-12-24 @ 7:40 PM
Ignite Modification Date: 2025-12-25 @ 5:20 PM
NCT ID: NCT00195403
Description: All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
Frequency Threshold: 0
Time Frame: None
Study: NCT00195403
Study Brief: A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Etanercept Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly. None None 3 998 142 998 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART View
Acute respiratory distress syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART View
Macular rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART View
Verruca vulgatis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART View
Burn NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART View
Sputum increased NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART View
Respiratory distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART View
Rhinorrhea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART View
Sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART View
Injection site itching NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Injection site edema NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Cellulitis NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Injection site burning sensation NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Edema NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Facial flushing NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Facial edema NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders WHO-ART View
Increased Serum Glutamic Pyruvate Transaminase NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders WHO-ART View
Increased Serum Glutamic-oxaloacetic Transminase NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders WHO-ART View
Hepatotoxicity NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders WHO-ART View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART View
Infection, aggravated NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART View
Tuberculosis, bones and joints NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART View
Abscess, pulmonary NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART View
Ear discharge NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART View
Shock, septic NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders WHO-ART View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders WHO-ART View
Back pain aggravated NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders WHO-ART View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHO-ART View
Thirst NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WHO-ART View
Weight decrease NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WHO-ART View
Weight increase NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WHO-ART View
Auto-antibody response NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Uveitis NON_SYSTEMATIC_ASSESSMENT Eye disorders WHO-ART View
Xerophthalmia NON_SYSTEMATIC_ASSESSMENT Eye disorders WHO-ART View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHO-ART View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WHO-ART View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WHO-ART View
Blood pressure high NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View
Lymph nodes enlarged NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHO-ART View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHO-ART View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders WHO-ART View
Azotemia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders WHO-ART View
Palpitation NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART View