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: 2025-12-25 @ 1:18 AM
Ignite Modification Date: 2025-12-25 @ 11:27 PM
NCT ID: NCT01753193
Description: None
Frequency Threshold: 0
Time Frame: From first dose of study drug (Day 1) through 168 weeks
Study: NCT01753193
Study Brief: An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Anifrolumab Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first. 1 None 50 218 164 218 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Hypothalamic pituitary adrenal axis suppression SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Oesophageal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Cyst SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Chikungunya virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Dengue fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Latent tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Mastoiditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Post procedural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Multiple injuries SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Spinal column stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Systemic lupus erythematosus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Hodgkin's disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Idiopathic intracranial hypertension SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
High risk pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 21.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Nephrotic syndrome SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Cervical polyp SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Dysfunctional uterine bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pulmonary infarction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Hidradenitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypercoagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Hyperleukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Leukaemoid reaction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Neutrophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Bifascicular block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Bundle branch block right SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Left atrial dilatation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Myocardial fibrosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.0 View
Eustachian tube dysfunction SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.0 View
Tympanic membrane perforation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.0 View
Hyperparathyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.0 View
Hyperparathyroidism primary SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.0 View
Thyroid mass SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.0 View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Blepharochalasis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Macular degeneration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Myopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Scleritis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Chronic gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastric mucosa erythema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastrointestinal angiodysplasia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Hiatus hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Internal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Irritable bowel syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Noninfective gingivitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Pancreatitis chronic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Acquired gene mutation SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Cyst SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Tenderness SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Cholecystitis chronic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Acarodermatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bacterial vaginosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Body tinea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bone abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bronchitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bronchitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Cervicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Dermatophytosis of nail SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gastrointestinal viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Genital candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Genital herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Infected bite SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Latent tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Lymphangitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Nail infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Oropharyngeal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Papilloma viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pelvic inflammatory disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Peritonsillar abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pharyngotonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pleurisy viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pulpitis dental SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Skin candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tinea manuum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tracheobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urinary tract infection fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Vulval abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Vulvovaginitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Zika virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Burns second degree SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Epicondylitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Injection related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Scar SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood immunoglobulin a decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Electrocardiogram qt shortened SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Lipids abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Liver function test increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Mycobacterium tuberculosis complex test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Nuclear magnetic resonance imaging brain abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Acquired mixed hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Vitamin d deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Fibromyalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Foot deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Myofascial pain syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Osteochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Osteopenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Scoliosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Spondylolisthesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Temporomandibular joint syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Haemangioma of bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Melanocytic naevus SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Seborrhoeic keratosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Skin papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Squamous cell carcinoma of the cervix SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Vulvovaginal warts SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Carpal tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Cerebrovascular disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Intercostal neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Lumbosacral radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Pineal gland cyst SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Visual field defect SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Bipolar disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Libido decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Hypertonic bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Breast discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Breast tenderness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Cervical dysplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Cervical polyp SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Dyspareunia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Endometrial hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Endometrial thickening SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Endometriosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Menometrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Menstruation delayed SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Menstruation irregular SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Polymenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Uterine cervical erosion SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Uterine haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Uterine polyp SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Vulvovaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Asthmatic crisis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Bronchial hyperreactivity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Catarrh SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Emphysema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Reflux laryngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Snoring SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Actinic keratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Hair growth abnormal SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Hypersensitivity vasculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Idiopathic urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Keratosis pilaris SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Mechanical urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Panniculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Peripheral coldness SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Peripheral venous disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Raynaud's phenomenon SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Vasculitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View