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 @ 4:19 AM
Ignite Modification Date: 2025-12-26 @ 3:20 AM
NCT ID: NCT02984020
Description: None
Frequency Threshold: 0
Time Frame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
Study: NCT02984020
Study Brief: Korean Post-marketing Surveillance for Xeljanz
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Post-Marketing Surveillance: Xeljanz Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years. 2 None 40 1009 261 1009 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Arthritis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Peritonsillar abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pyelonephritis acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Sinusitis fungal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Cartilage injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Femoral neck fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Foot fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Humerus fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Spinal compression fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Flank pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Synovitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Interstitial lung disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pelvic fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Bursitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Mononeuritis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypercholesterolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyperlipidaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Bursitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Joint effusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Musculoskeletal discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Rheumatoid arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Rheumatoid nodule NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Rotator cuff syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Spinal osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Tenosynovitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Cerebral artery occlusion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Cerebral artery stenosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Cerebral ischaemia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Cognitive disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Memory impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Post herpetic neuralgia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Tension headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Renal cyst NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Breast mass NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Breast pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Heavy menstrual bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Scrotal pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Upper respiratory tract inflammation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Vocal cord thickening NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Decubitus ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Hyperkeratosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Skin disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tinea cruris NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tinea versicolour NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tuberculosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Vaginal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Foot fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Humerus fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Muscle rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Wrist fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Alanine aminotransferase abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Aspartate aminotransferase abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood cholesterol increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Hepatic enzyme increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
High density lipoprotein increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Dyslipidaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Deafness NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Vertigo positional NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Gastric ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Hyperchlorhydria NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Iron deficiency anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Type IIa hyperlipidaemia NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 24.1 View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Diplopia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Gastritis erosive NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Gastrointestinal disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Gastrointestinal inflammation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Large intestine polyp NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Mouth ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Face oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Generalised oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Swelling face NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Gallbladder polyp NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Hepatic steatosis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Liver disorder NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Abscess limb NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Gingivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Herpes simplex NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Periodontitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Liver function test abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Liver function test increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View