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 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:47 PM
NCT ID: NCT00195494
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00195494
Study Brief: Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Year 1 M / Year 2 M Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs). No reduction of MTX dose is permitted in year two. None None 12 None 79 None View
Year 1 M+Placebo Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites. MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8. None None 34 None 241 None View
Year 1 E+M / Year 2 E+M Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection). Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two. None None 8 None 91 None View
Year 1 E+M / Year 2 E Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites). None None 10 None 89 None View
Year 1 E+M Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection). MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8. None None 33 None 246 None View
Year 1 M / Year 2 E+M Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection). Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two. None None 11 None 71 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intervertebral disc disorder NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ischaemia NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Angina unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Aterial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Photophobia NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Appendicitis perforated NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General gastrointestinal disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mechanical ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
General physical health deterioration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Gallbladder disorder NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Acute sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chronic sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lyme disease NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic athritis staphylococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Streptococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Accidental overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Joint injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pelvic fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Radius fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hepatic enzyme increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Transaminases increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Haemarthrosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Intervetebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rheumatoid arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Basal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Bowen's disease NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Breast cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Chronic lymphocytic leukamia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Tongue neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebral haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope vasovagal NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sleep disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Idiopathic pulmonary fibrosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Interstitial lung disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hip arthroplasty NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hospitalisation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infarction NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Aortic valve stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrio ventricular block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mitral valve incompetence NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Systemic inflammatory response system NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bursitis infected staphylococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Device failure NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ligament injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skull fractured base NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Arthropathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Spondylolisthesis acquired NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gastrointestinal carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung cancer metastatic NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Malignant melanoma of sights other than skin NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Metastases to lung NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pancreatic carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Transitional cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebellar infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hydrocephalus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sciatica NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal and urinary disorders NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal colic NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Testicular torsion NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal prolapse NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cholecystectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Haemorrhoid operation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Aneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood and lymphatic NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiac disorders NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ear and labyrinth NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarhhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Administration site conditions NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Post procedural nausea NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Investigations NON_SYSTEMATIC_ASSESSMENT Investigations None View
Rheumatoid arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychiatric NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal and urinary NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infections and Infestations NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT General disorders None View
Rhinitis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injury, poisoning and procedural complications NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neoplasms benign NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View