Adverse Events Module

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 @ 7:39 PM
Ignite Modification Date: 2025-12-25 @ 5:19 PM
NCT ID: NCT00357903
Description: The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Frequency Threshold: 5
Time Frame: Up to 11.29 years
Study: NCT00357903
Study Brief: Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Total Adults None None None 293 581 484 581 View
Pediatric Subjects None None None 16 58 49 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Mental disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Calculus ureteric SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Henoch-Schonlein purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Panniculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Splenic infarction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Arrhythmia supraventricular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Coronary artery occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cyanosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Diastolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Ischaemic cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Sick sinus syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Gastrointestinal arteriovenous malformation SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 12.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 12.0 View
Abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Abdominal hernia obstructive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Colitis ischaemic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Diverticular perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Diverticulum oesophageal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Gastroduodenitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Hiatus hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Oesophageal rupture SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Oesophageal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Oesophageal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Rectal prolapse SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Retroperitoneal haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Adverse event SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Condition aggravated SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Impaired healing SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Necrosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Autoimmune hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Hepatitis alcoholic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Perforation bile duct SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Allergy to arthropod sting SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 12.0 View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 12.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 12.0 View
Sarcoidosis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 12.0 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Abscess intestinal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Arthritis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Atypical mycobacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Bursitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Cellulitis staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Cellulitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Diarrhoea infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Escherichia bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Fungal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Graft infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Hepatitis B SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Incisional hernia gangrenous SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Meningitis aseptic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Meningococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Peritonitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pneumococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Post procedural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Post procedural pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Proteus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pseudomembranous colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Sepsis syndrome SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Shigella infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Staphylococcal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Toxic shock syndrome streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Urinary tract infection enterococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Caustic injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Chest injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Device malfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Dislocation of joint prosthesis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Extradural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Eye injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Fibula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Jaw fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Joint dislocation postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Medical device complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Open fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Soft tissue injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Arteriogram coronary SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Blood pressure abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Bone density decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Cardiac ventriculogram left SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Catheterisation cardiac SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Heart rate abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Diabetic foot SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Type 1 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Foot deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Fracture delayed union SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Haemarthrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Hand deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Intervertebral disc degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Intervertebral disc disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Juvenile arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Limb discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Low turnover osteopathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Muscle haemorrhage SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Muscle necrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Osteolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Pelvic deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Rheumatoid arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Spinal column stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Synovial cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Synovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Acute myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
B-cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Bile duct cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Bladder transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Breast cancer female SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Breast cancer in situ SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Bronchial carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Cervix carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Cervix carcinoma stage 0 SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Colon adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Colon cancer recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Follicle centre lymphoma diffuse small cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Gastrointestinal tract adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Gliosarcoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Histiocytosis haematophagic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Hodgkin's disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Laryngeal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Laryngeal cancer stage I SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Lentigo maligna stage unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Lung neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Lymphocytic leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Lymphocytic lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Meningioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Meningioma benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastases to liver SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastases to ovary SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastases to small intestine SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Non-Hodgkin's lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Non-small cell lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Non-small cell lung cancer stage I SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Ovarian cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Ovarian cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Ovarian epithelial cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Prolymphocytic leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Renal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Thyroid neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Brain stem infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Carpal tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Cerebral thrombosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Intracranial aneurysm SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Lumbar radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Multiple sclerosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Bipolar disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Renal tubular necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Uterine polyp SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
Vaginal erythema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Diffuse alveolar damage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Pulmonary sarcoidosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Dermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Joint prosthesis user SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 12.0 View
Cardiac ablation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Cholecystectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Fracture treatment SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Hip arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Joint arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Knee arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Leg amputation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Shoulder arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Shoulder operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Angiopathy SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Aortic aneurysm rupture SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Infarction SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Peripheral embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Peripheral vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Conjunctivitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View