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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Etanercept | Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months. | None | None | 36 | 880 | 455 | 880 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Acute pulmonary oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Pancreatitis acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Tooth abscess | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Bile duct stone | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA | View |
| Hepatic function abnormal | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Transaminases increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Hip fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Intervertebral disc space narrowing | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Joint effusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Cervix carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | View |
| Small cell lung cancer stage unspecified | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Transient ischaemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA | View |
| Suicide attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA | View |
| Renal failure acute | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA | View |
| Salpingitis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA | View |
| Lung neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Respiratory arrest | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Alopecia universalis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Dermatitis allergic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Cholecystectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA | View |
| Parathyroidectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA | View |
| Thyroidectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA | View |
| Lymphoedema | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Acute coronary syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Uveitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Hyperlipidaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Hypertriglyceridaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Iron deficiency anaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Arthropathy | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Bursitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Demyelination plaque | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Fibromyalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Finger deformity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Joint ankylosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Joint effusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Joint swelling | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Mobility decreased | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Muscle weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Musculoskeletal stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Osteonecrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Periarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Polyarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Psoriatic arthropathy | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Rheumatoid arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Rotator cuff syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Scoliosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Sjogren's syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Synovial disorder | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Synovitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Tendonitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Plantar fasciitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Bladder papilloma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | View |
| Gallbladder polyp | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | View |
| Haemangioma of liver | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | View |
| Carpal tunnel syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Head titubation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Hypoaesthesia facial | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Agitation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Emotional disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Fear of disease | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Escherichia urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA | View |
| Renal failure chronic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA | View |
| Breast mass | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA | View |
| Breast pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA | View |
| Epididymitis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA | View |
| Genital rash | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA | View |
| Libido disorder | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA | View |
| Metrorrhagia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA | View |
| Prostatitis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA | View |
| Acute tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| H1N1 influenza | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Laryngitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Respiratory tract infection viral | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Dermatitis acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Dermatitis allergic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Dermatitis bullous | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Dermatitis psoriasiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Nail psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Neurodermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Onychomycosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Rash papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Rash pustular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Skin lesion | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Skin striae | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Stevens-Johnson syndrome | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Tinea versicolour | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
| Peripheral coldness | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
| Venous insufficiency | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
| (localized) arthritis | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| acute sciatica and lumbago | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Breast tumor | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Decreased morning stiffness | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| deformities of upper limbs bilaterally | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| elbow Psoriasis | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| hip arthritis | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| hip pain and restriction of mobility | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Hypothermic lower limbs without pulse | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Improvement of spine mobility | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Increased inflammatory markers | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| injury of gluteal muscle | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| jaundice (biliary cirrhosis) | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| joint pain, enthesitis | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| localized nettle rash | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| localized tender joints | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Lower limb deformities | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Measurement of the thoracic cage | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Mild conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| mild synovitis | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| mobile, painful axillary lymph node | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Oligoarthritis | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Pain and restriction of mobility | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Paresthetic thigh pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| pelvic fracture (fall) | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| pelvic restriction of mobility | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Permanent disability in hand | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Plantar aponeurosis | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| possible carpal tube syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| relapsed rash psoriasiform | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Remission of scalp psoriasis | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| restriction of hip mobility | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Restriction of movement of thoracic cage | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Restriction of shoulder mobility bilaterally | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Scalp pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| sciatica and lumbago | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| secondary osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Shrinkage of tendon | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Swollen joints with restriction of mobility | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| synovitis of limbs | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| tender and swollen joints | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| tender hip | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| tender joints of lower limb | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| tender spine | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Unstable gait | NON_SYSTEMATIC_ASSESSMENT | General disorders | Reported term | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA | View |
| Infectious mononucleosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA | View |
| Leukocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA | View |
| Lymphocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA | View |
| Splenomegaly | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA | View |
| Thrombocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA | View |
| Angina unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Sinus arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA | View |
| Cushing's syndrome | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Iridocyclitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Aphthous stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Aptyalism | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Epigastric discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Gastric infection | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Gingivitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Irritable bowel syndrome | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Condition aggravated | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Drug ineffective | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Gait disturbance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Injection site irritation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Injection site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Injection site pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Injection site rash | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Local reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Hepatic steatosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA | View |
| Hepatomegaly | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA | View |
| Hypertransaminasaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA | View |
| Hypertransaminasaemia (Lab Technical Error) | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA | View |
| Peliosis hepatis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA | View |
| Drug eruption | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA | View |
| Eyelid oedema | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA | View |
| Febrile infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Herpes ophthalmic | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Oral fungal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pilonidal cyst | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Soft tissue infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Tooth abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Vaginal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Animal bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Joint injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Joint sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Alanine aminotransferase decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Anti-HBs antibody positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Aspartate aminotransferase decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Basophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Basophil count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood alkaline phosphatase decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood calcium increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood calcium increased (Lab Technical Error) | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood cholesterol decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood cholesterol increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood creatinine decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood glucose decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood glucose increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood phosphorus increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood phosphorus increased (Lab Technical Error) | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood potassium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood potassium increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood pressure systolic decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood sodium increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood triglycerides decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood triglycerides increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood urea decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood urea increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Blood urine present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| C-reactive protein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Differential white blood cell count abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Eosinophil count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Haematocrit decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Haematocrit normal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| High density lipoprotein decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| High density lipoprotein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Low density lipoprotein decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Low density lipoprotein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Lymphocyte count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Monocyte count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Neutrophil count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Platelet count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Red blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Red blood cell sedimentation rate increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Transaminases decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Transaminases increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Weight increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| White blood cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| White blood cell count normal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Metrorrhagia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Dyslipidaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Hypercalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |