Study: NCT02344290

Adverse event: Anaemia deficiencies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Anaemias NEC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 3888 at risk

Adverse event: Anaemias due to chronic disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Leukopenias NEC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Lymphatic system disorders NEC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Neutropenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Thrombocytopenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Cardiac conduction disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Coronary artery disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Heart failures NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 3888 at risk

Adverse event: Ischaemic coronary artery disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 3888 at risk

Adverse event: Left ventricular failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Mitral valvular disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Noninfectious pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Pericardial disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Rate and rhythm disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Supraventricular arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 3888 at risk

Adverse event: Ventricular arrhythmias and cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Hearing losses
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Inner ear signs and symptoms
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Adrenal cortical hypofunctions
Serious: yes
Organ System: Endocrine disorders
Frequency: 4 affected / 3888 at risk

Adverse event: Hyperparathyroid disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Cataract conditions
Serious: yes
Organ System: Eye disorders
Frequency: 12 affected / 3888 at risk

Adverse event: Choroid and vitreous structural change, deposit and degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Glaucomas (excl congenital)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Iris and uveal tract infections, irritations and inflammations
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Optic disc abnormalities NEC
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Optic nerve bleeding and vascular disorders
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Retinal structural change, deposit and degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Visual impairment and blindness (excl colour blindness)
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Abdominal hernias NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Acute and chronic pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 3888 at risk

Adverse event: Anal and rectal disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Anal and rectal pains
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Colitis (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3888 at risk

Adverse event: Diarrhoea (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 3888 at risk

Adverse event: Duodenal and small intestinal stenosis and obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3888 at risk

Adverse event: Duodenal ulcers and perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Gastritis (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 3888 at risk

Adverse event: Gastrointestinal and abdominal pains (excl oral and throat)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 3888 at risk

Adverse event: Gastrointestinal atonic and hypomotility disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Gastrointestinal inflammatory disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Gastrointestinal signs and symptoms NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3888 at risk

Adverse event: Gastrointestinal stenosis and obstruction NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 3888 at risk

Adverse event: Gastrointestinal ulcers and perforation, site unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Haemorrhoids and gastrointestinal varices (excl oesophageal)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Inguinal hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 3888 at risk

Adverse event: Intestinal haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Intestinal ulcers and perforation NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Large intestinal stenosis and obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Nausea and vomiting symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 3888 at risk

Adverse event: Non-site specific gastrointestinal haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Oesophageal stenosis and obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Oesophageal ulcers and perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Peritoneal and retroperitoneal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Rectal inflammations NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Salivary gland disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Umbilical hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Asthenic conditions
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Body temperature altered
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Febrile disorders
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 3888 at risk

Adverse event: General signs and symptoms NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Healing abnormal NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Inflammations
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Oedema NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Pain and discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 3888 at risk

Adverse event: Ulcers NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Cholecystitis and cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 3888 at risk

Adverse event: Hepatic and hepatobiliary disorders NEC
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Hepatic enzymes and function abnormalities
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Hepatic fibrosis and cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Hepatic vascular disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Obstructive bile duct disorders (excl neoplasms)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Allergies to foods, food additives, drugs and other chemicals
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Anaphylactic and anaphylactoid responses
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Abdominal and gastrointestinal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 36 affected / 3888 at risk

Adverse event: Actinomycotic infectious disorders
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3888 at risk

Adverse event: Atypical mycobacterial infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3888 at risk

Adverse event: Bacterial infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 41 affected / 3888 at risk

Adverse event: Bone and joint infections
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 3888 at risk

Adverse event: Breast infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3888 at risk

Adverse event: Campylobacter infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3888 at risk

Adverse event: Candida infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3888 at risk

Adverse event: Central nervous system and spinal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 3888 at risk

Adverse event: Clostridia infections
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 3888 at risk

Adverse event: Cryptococcal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3888 at risk

Adverse event: Dental and oral soft tissue infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3888 at risk

Adverse event: Escherichia infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3888 at risk

Adverse event: Eye and eyelid infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3888 at risk

Adverse event: Female reproductive tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3888 at risk

Adverse event: Flaviviral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 3888 at risk

Adverse event: Fungal infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3888 at risk

Adverse event: Haemophilus infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3888 at risk

Adverse event: Hepatitis virus infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3888 at risk

Adverse event: Hepatobiliary and spleen infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3888 at risk

Adverse event: Herpes viral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 3888 at risk

Adverse event: Infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 3888 at risk

Adverse event: Influenza viral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 3888 at risk

Adverse event: Lower respiratory tract and lung infections
Serious: yes
Organ System: Infections and infestations
Frequency: 71 affected / 3888 at risk

Adverse event: Male reproductive tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3888 at risk

Adverse event: Muscle and soft tissue infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3888 at risk

Adverse event: Neisseria infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3888 at risk

Adverse event: Nematode infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3888 at risk

Adverse event: Orthopox viral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3888 at risk

Adverse event: Parainfluenzae viral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3888 at risk

Adverse event: Plasmodia infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3888 at risk

Adverse event: Pneumocystis infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3888 at risk

Adverse event: Rhinoviral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3888 at risk

Adverse event: Rickettsial infectious disorders NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3888 at risk

Adverse event: Salmonella infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3888 at risk

Adverse event: Sepsis, bacteraemia, viraemia and fungaemia NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 20 affected / 3888 at risk

Adverse event: Skin structures and soft tissue infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3888 at risk

Adverse event: Staphylococcal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3888 at risk

Adverse event: Streptococcal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 3888 at risk

Adverse event: Toxoplasma infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3888 at risk

Adverse event: Treponema infections
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 3888 at risk

Adverse event: Tuberculous infections
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 3888 at risk

Adverse event: Upper respiratory tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3888 at risk

Adverse event: Urinary tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 23 affected / 3888 at risk

Adverse event: Vascular infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3888 at risk

Adverse event: Viral infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 3888 at risk

Adverse event: Abdominal and gastrointestinal injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3888 at risk

Adverse event: Cerebral injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 3888 at risk

Adverse event: Chest and respiratory tract injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 3888 at risk

Adverse event: Eye injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3888 at risk

Adverse event: Fractures and dislocations NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 3888 at risk

Adverse event: Gastrointestinal and hepatobiliary procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3888 at risk

Adverse event: Limb fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 43 affected / 3888 at risk

Adverse event: Muscle, tendon and ligament injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3888 at risk

Adverse event: Non-site specific injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 3888 at risk

Adverse event: Non-site specific procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3888 at risk

Adverse event: Overdoses NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 3888 at risk

Adverse event: Pelvic fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3888 at risk

Adverse event: Poisoning and toxicity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3888 at risk

Adverse event: Site specific injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3888 at risk

Adverse event: Skin injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3888 at risk

Adverse event: Skull fractures, facial bone fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3888 at risk

Adverse event: Spinal cord injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3888 at risk

Adverse event: Spinal fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 3888 at risk

Adverse event: Thermal burns
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3888 at risk

Adverse event: Thoracic cage fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 3888 at risk

Adverse event: Carbohydrate tolerance analyses (incl diabetes)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 3888 at risk

Adverse event: Hepatobiliary function diagnostic procedures
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 3888 at risk

Adverse event: Platelet analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3888 at risk

Adverse event: Red blood cell analyses
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 3888 at risk

Adverse event: Renal function analyses
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 3888 at risk

Adverse event: Skeletal and cardiac muscle analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3888 at risk

Adverse event: Triglyceride analyses
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 3888 at risk

Adverse event: Vascular tests NEC (incl blood pressure)
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 3888 at risk

Adverse event: White blood cell analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3888 at risk

Adverse event: Calcium metabolism disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Diabetes mellitus (incl subtypes)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Diabetic complications NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Diabetic complications neurological
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Disorders of purine metabolism
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Elevated triglycerides
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3888 at risk

Adverse event: General nutritional disorders NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 3888 at risk

Adverse event: Hyperglycaemic conditions NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 3888 at risk

Adverse event: Hypoglycaemic conditions NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Metabolic acidoses (excl diabetic acidoses)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Metabolic alkaloses
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Phosphorus metabolism disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Sodium imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Total fluid volume decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Arthropathies NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Bone disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 3888 at risk

Adverse event: Cartilage disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Fractures NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Intervertebral disc disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Joint related disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 3888 at risk

Adverse event: Joint related signs and symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 3888 at risk

Adverse event: Metabolic bone disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Muscle infections and inflammations
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Muscle pains
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Muscle weakness conditions
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Musculoskeletal and connective tissue pain and discomfort
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 3888 at risk

Adverse event: Myopathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 3888 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 3888 at risk

Adverse event: Spine and neck deformities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 3888 at risk

Adverse event: Anal canal neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3888 at risk

Adverse event: B-cell lymphomas NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Bladder neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Breast and nipple neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 3888 at risk

Adverse event: Burkitt's lymphomas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Central nervous system neoplasms malignant NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Cervix neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3888 at risk

Adverse event: Colorectal neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3888 at risk

Adverse event: Endocrine neoplasms malignant and unspecified NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Extranodal marginal zone B-cell lymphomas (low grade B-cell)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Fallopian tube neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Fibrous histiocytomas malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Gallbladder neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Hepatic neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3888 at risk

Adverse event: Hodgkin's disease NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 3888 at risk

Adverse event: Leukaemias acute lymphocytic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Leukaemias chronic myeloid
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3888 at risk

Adverse event: Lip and oral cavity neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3888 at risk

Adverse event: Liposarcomas malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Myeloproliferative disorders (excl leukaemias)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Nervous system neoplasms unspecified malignancy NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Non-Hodgkin's lymphomas NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Non-small cell neoplasms malignant of the respiratory tract cell type specified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3888 at risk

Adverse event: Oropharyngeal, nasopharyngeal and tonsillar neoplasms malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Ovarian neoplasms benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Ovarian neoplasms malignant (excl germ cell)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Plasma cell myelomas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3888 at risk

Adverse event: Prostatic neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 3888 at risk

Adverse event: Renal neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Respiratory tract and pleural neoplasms malignant cell type unspecified NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3888 at risk

Adverse event: Skin melanomas (excl ocular)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Skin neoplasms malignant and unspecified (excl melanoma)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Uterine neoplasms benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3888 at risk

Adverse event: Vulval neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3888 at risk

Adverse event: Acute polyneuropathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Central nervous system aneurysms and dissections
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Central nervous system haemorrhages and cerebrovascular accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 3888 at risk

Adverse event: Cervical spinal cord and nerve root disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Coordination and balance disturbances
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Cortical dysfunction NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Cranial nerve disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Dementia (excl Alzheimer's type)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Disturbances in consciousness NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 15 affected / 3888 at risk

Adverse event: Encephalopathies NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Facial cranial nerve disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Generalised tonic-clonic seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Headaches NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 3888 at risk

Adverse event: Hydrocephalic conditions
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Increased intracranial pressure disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Lumbar spinal cord and nerve root disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Memory loss (excl dementia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Migraine headaches
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Mononeuropathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Nervous system disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Neurological signs and symptoms NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 3888 at risk

Adverse event: Paraesthesias and dysaesthesias
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Paralysis and paresis (excl cranial nerve)
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 3888 at risk

Adverse event: Parkinson's disease and parkinsonism
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Peripheral neuropathies NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Seizures and seizure disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 3888 at risk

Adverse event: Speech and language abnormalities
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Spinal cord and nerve root disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 3888 at risk

Adverse event: Structural brain disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Transient cerebrovascular events
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Abortions spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3888 at risk

Adverse event: Device issues NEC
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 3888 at risk

Adverse event: Abnormal behaviour NEC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Anxiety symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Behaviour and socialisation disturbances
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Bipolar disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Confusion and disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Delusional symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Depressive disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 3888 at risk

Adverse event: Mental disorders NEC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 10 affected / 3888 at risk

Adverse event: Mood alterations with manic symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Panic attacks and disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Psychotic disorder NEC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 8 affected / 3888 at risk

Adverse event: Schizoaffective and schizophreniform disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Schizophrenia NEC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Somatic symptom disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Substance related and addictive disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 9 affected / 3888 at risk

Adverse event: Suicidal and self-injurious behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 33 affected / 3888 at risk

Adverse event: Genital and urinary tract disorders NEC
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Nephropathies and tubular disorders NEC
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Renal failure and impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 25 affected / 3888 at risk

Adverse event: Renal lithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 3888 at risk

Adverse event: Structural and obstructive urethral disorders (excl congenital)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Urinary tract lithiasis NEC
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Urinary tract signs and symptoms NEC
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Breast disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Cervix disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Menstruation and uterine bleeding NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Menstruation with increased bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 3888 at risk

Adverse event: Ovarian and fallopian tube cysts and neoplasms
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Pelvis and broad ligament disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Prostatic neoplasms and hypertrophy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Testicular and epididymal disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Uterine disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Breathing abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 3888 at risk

Adverse event: Bronchial conditions NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Bronchospasm and obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 3888 at risk

Adverse event: Conditions associated with abnormal gas exchange
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Coughing and associated symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Laryngeal and adjacent sites disorders NEC (excl infections and neoplasms)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Lower respiratory tract signs and symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Parenchymal lung disorders NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Pneumothorax and pleural effusions NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 3888 at risk

Adverse event: Pulmonary oedemas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Pulmonary thrombotic and embolic conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 3888 at risk

Adverse event: Respiratory failures (excl neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 3888 at risk

Adverse event: Angioedemas
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Dermatitis and eczema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Lipodystrophies
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Pruritus NEC
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Skin and subcutaneous tissue ulcerations
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Criminal activity
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 3888 at risk

Adverse event: Cardiac therapeutic procedures NEC
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3888 at risk

Adverse event: Gastric therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3888 at risk

Adverse event: Hernia repairs
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3888 at risk

Adverse event: Joint therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 3888 at risk

Adverse event: Limb therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 3888 at risk

Adverse event: Psychiatric therapies
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3888 at risk

Adverse event: Renal therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3888 at risk

Adverse event: Small intestine therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3888 at risk

Adverse event: Spine and spinal cord therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 3888 at risk

Adverse event: Therapeutic procedures NEC
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3888 at risk

Adverse event: Uterine therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3888 at risk

Adverse event: Haemorrhages NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Lymphoedemas
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Non-site specific embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3888 at risk

Adverse event: Non-site specific necrosis and vascular insufficiency NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Peripheral embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 3888 at risk

Adverse event: Peripheral vasoconstriction, necrosis and vascular insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3888 at risk

Adverse event: Vascular hypertensive disorders NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 3888 at risk

Adverse event: Vascular hypotensive disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 3888 at risk

Adverse event: Physical examination procedures and organ system status
Serious: no
Organ System: Investigations
Frequency: 62 affected / 3888 at risk

Adverse event: Renal function analyses
Serious: no
Organ System: Investigations
Frequency: 125 affected / 3888 at risk

Adverse event: Diabetes mellitus (incl subtypes)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 238 affected / 3888 at risk

Adverse event: General nutritional disorders NEC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 66 affected / 3888 at risk

Adverse event: Muscle pains
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 77 affected / 3888 at risk

Adverse event: Musculoskeletal and connective tissue pain and discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 3888 at risk

Adverse event: Vascular hypertensive disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 37 affected / 3888 at risk

Adverse event: Anaemia deficiencies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3881 at risk

Adverse event: Anaemias NEC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 3881 at risk

Adverse event: Coagulopathies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Leukopenias NEC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Lymphatic system disorders NEC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Neutropenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Thrombocytopenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Cardiac signs and symptoms NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Heart failures NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 3881 at risk

Adverse event: Ischaemic coronary artery disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 3881 at risk

Adverse event: Left ventricular failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Noninfectious pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Pericardial disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 3881 at risk

Adverse event: Rate and rhythm disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Supraventricular arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 3881 at risk

Adverse event: Ventricular arrhythmias and cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 3881 at risk

Adverse event: Inner ear signs and symptoms
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 3881 at risk

Adverse event: Posterior pituitary disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Cataract conditions
Serious: yes
Organ System: Eye disorders
Frequency: 6 affected / 3881 at risk

Adverse event: Orbital infections, inflammations and irritations
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Retinal structural change, deposit and degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Abdominal hernias NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Acute and chronic pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 3881 at risk

Adverse event: Anal and rectal disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Benign neoplasms gastrointestinal (excl oral cavity)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Colitis (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 3881 at risk

Adverse event: Diaphragmatic hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Diarrhoea (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Duodenal and small intestinal stenosis and obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Gastric and oesophageal haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Gastritis (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Gastrointestinal and abdominal pains (excl oral and throat)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Gastrointestinal atonic and hypomotility disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Gastrointestinal disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Gastrointestinal inflammatory disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3881 at risk

Adverse event: Gastrointestinal signs and symptoms NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Gastrointestinal stenosis and obstruction NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Gastrointestinal vascular occlusion and infarction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Gingival disorders, signs and symptoms NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Haemorrhoids and gastrointestinal varices (excl oesophageal)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Inguinal hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Intestinal ulcers and perforation NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Nausea and vomiting symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Non-site specific gastrointestinal haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 3881 at risk

Adverse event: Oesophageal ulcers and perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Oesophagitis (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Oral soft tissue disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Umbilical hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Body temperature altered
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Febrile disorders
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Hernias NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Inflammations
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Pain and discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 24 affected / 3881 at risk

Adverse event: Bile duct infections and inflammations
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 3881 at risk

Adverse event: Cholecystitis and cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 13 affected / 3881 at risk

Adverse event: Cholestasis and jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Hepatic and hepatobiliary disorders NEC
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Hepatic fibrosis and cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Hepatic vascular disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Hepatocellular damage and hepatitis NEC
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Obstructive bile duct disorders (excl neoplasms)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 3881 at risk

Adverse event: Structural and other bile duct disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Acute and chronic sarcoidosis
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Allergic conditions NEC
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Anaphylactic and anaphylactoid responses
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Abdominal and gastrointestinal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 41 affected / 3881 at risk

Adverse event: Adenoviral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3881 at risk

Adverse event: Atypical mycobacterial infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3881 at risk

Adverse event: Bacterial infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 30 affected / 3881 at risk

Adverse event: Bone and joint infections
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 3881 at risk

Adverse event: Caliciviral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3881 at risk

Adverse event: Candida infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3881 at risk

Adverse event: Central nervous system and spinal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3881 at risk

Adverse event: Clostridia infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3881 at risk

Adverse event: Cytomegaloviral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3881 at risk

Adverse event: Dental and oral soft tissue infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3881 at risk

Adverse event: Ear infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3881 at risk

Adverse event: Enterococcal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3881 at risk

Adverse event: Escherichia infections
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 3881 at risk

Adverse event: Female reproductive tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3881 at risk

Adverse event: Flaviviral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 3881 at risk

Adverse event: Hepatitis virus infections
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 3881 at risk

Adverse event: Hepatobiliary and spleen infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3881 at risk

Adverse event: Herpes viral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 3881 at risk

Adverse event: Infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 3881 at risk

Adverse event: Influenza viral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 3881 at risk

Adverse event: Legionella infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3881 at risk

Adverse event: Leptospira infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3881 at risk

Adverse event: Listeria infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3881 at risk

Adverse event: Lower respiratory tract and lung infections
Serious: yes
Organ System: Infections and infestations
Frequency: 66 affected / 3881 at risk

Adverse event: Male reproductive tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 3881 at risk

Adverse event: Muscle and soft tissue infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3881 at risk

Adverse event: Neisseria infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3881 at risk

Adverse event: Orthopox viral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3881 at risk

Adverse event: Parainfluenzae viral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3881 at risk

Adverse event: Pneumocystis infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3881 at risk

Adverse event: Sepsis, bacteraemia, viraemia and fungaemia NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 3881 at risk

Adverse event: Shigella infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3881 at risk

Adverse event: Skin structures and soft tissue infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3881 at risk

Adverse event: Staphylococcal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3881 at risk

Adverse event: Streptococcal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3881 at risk

Adverse event: Toxoplasma infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3881 at risk

Adverse event: Treponema infections
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 3881 at risk

Adverse event: Tuberculous infections
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 3881 at risk

Adverse event: Upper respiratory tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 3881 at risk

Adverse event: Urinary tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 3881 at risk

Adverse event: Viral infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 3881 at risk

Adverse event: Abdominal and gastrointestinal injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3881 at risk

Adverse event: Accidental exposures to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3881 at risk

Adverse event: Cerebral injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 3881 at risk

Adverse event: Chemical injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3881 at risk

Adverse event: Chest and respiratory tract injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3881 at risk

Adverse event: Conditions caused by cold
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3881 at risk

Adverse event: Eye injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3881 at risk

Adverse event: Fractures and dislocations NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3881 at risk

Adverse event: Limb fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 50 affected / 3881 at risk

Adverse event: Musculoskeletal procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3881 at risk

Adverse event: Non-site specific injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 3881 at risk

Adverse event: Non-site specific procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 3881 at risk

Adverse event: Overdoses NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 3881 at risk

Adverse event: Pelvic fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3881 at risk

Adverse event: Poisoning and toxicity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3881 at risk

Adverse event: Product administration errors and issues
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 3881 at risk

Adverse event: Radiation injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3881 at risk

Adverse event: Site specific injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 3881 at risk

Adverse event: Skin injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3881 at risk

Adverse event: Skull fractures, facial bone fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3881 at risk

Adverse event: Spinal fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3881 at risk

Adverse event: Thermal burns
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3881 at risk

Adverse event: Thoracic cage fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3881 at risk

Adverse event: Cardiac function diagnostic procedures
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3881 at risk

Adverse event: ECG investigations
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3881 at risk

Adverse event: Hepatobiliary function diagnostic procedures
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 3881 at risk

Adverse event: Physical examination procedures and organ system status
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 3881 at risk

Adverse event: Red blood cell analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3881 at risk

Adverse event: Renal function analyses
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 3881 at risk

Adverse event: Skeletal and cardiac muscle analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3881 at risk

Adverse event: Tissue enzyme analyses NEC
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3881 at risk

Adverse event: Triglyceride analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3881 at risk

Adverse event: Vascular tests NEC (incl blood pressure)
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 3881 at risk

Adverse event: White blood cell analyses
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 3881 at risk

Adverse event: Calcium metabolism disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Diabetes mellitus (incl subtypes)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 3881 at risk

Adverse event: Diabetic complications NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Disorders of purine metabolism
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3881 at risk

Adverse event: General nutritional disorders NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 3881 at risk

Adverse event: Hyperglycaemic conditions NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3881 at risk

Adverse event: Hypoglycaemic conditions NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Lipid metabolism and deposit disorders NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Metabolic acidoses (excl diabetic acidoses)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3881 at risk

Adverse event: Potassium imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3881 at risk

Adverse event: Sodium imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3881 at risk

Adverse event: Total fluid volume decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Arthropathies NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Bone disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Fracture complications
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Intervertebral disc disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Joint related disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Joint related signs and symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 3881 at risk

Adverse event: Muscle pains
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3881 at risk

Adverse event: Muscle related signs and symptoms NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Muscle weakness conditions
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Musculoskeletal and connective tissue pain and discomfort
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Myopathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3881 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 3881 at risk

Adverse event: Rheumatoid arthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Spine and neck deformities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 3881 at risk

Adverse event: Synovial disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Tendon disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 3881 at risk

Adverse event: Anal canal neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 3881 at risk

Adverse event: B-cell lymphomas NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3881 at risk

Adverse event: Bile duct neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Bladder neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3881 at risk

Adverse event: Bone neoplasms unspecified malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Breast and nipple neoplasms benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Breast and nipple neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 3881 at risk

Adverse event: Colorectal neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 3881 at risk

Adverse event: Gallbladder neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3881 at risk

Adverse event: Gastric neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3881 at risk

Adverse event: Glial tumours malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3881 at risk

Adverse event: Gliomas benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Hodgkin's disease NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3881 at risk

Adverse event: Laryngeal neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Lip and oral cavity neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3881 at risk

Adverse event: Lymphomas unspecified NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3881 at risk

Adverse event: Mediastinal neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Metastases to specified sites
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 3881 at risk

Adverse event: Neoplasms malignant site unspecified NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3881 at risk

Adverse event: Nervous system neoplasms unspecified malignancy NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 3881 at risk

Adverse event: Non-Hodgkin's lymphomas NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Non-small cell neoplasms malignant of the respiratory tract cell type specified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 3881 at risk

Adverse event: Oncologic complications and emergencies
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Oropharyngeal, nasopharyngeal and tonsillar neoplasms malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Ovarian neoplasms benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Ovarian neoplasms malignant (excl germ cell)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Plasma cell myelomas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Prostatic neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 3881 at risk

Adverse event: Renal neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Renal pelvis and ureter neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Respiratory tract and pleural neoplasms malignant cell type unspecified NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Respiratory tract small cell carcinomas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Salivary gland neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Skin melanomas (excl ocular)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Skin neoplasms benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Skin neoplasms malignant and unspecified (excl melanoma)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Soft tissue neoplasms benign NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3881 at risk

Adverse event: Uterine neoplasms benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 3881 at risk

Adverse event: Alzheimer's disease (incl subtypes)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Central nervous system aneurysms and dissections
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Central nervous system haemorrhages and cerebrovascular accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 3881 at risk

Adverse event: Central nervous system vascular disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Cortical dysfunction NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Demyelinating disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Disturbances in consciousness NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 3881 at risk

Adverse event: Encephalopathies NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Encephalopathies toxic and metabolic
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Headaches NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3881 at risk

Adverse event: Hydrocephalic conditions
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Increased intracranial pressure disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Lumbar spinal cord and nerve root disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Migraine headaches
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Mononeuropathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Motor neurone diseases
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Neurological signs and symptoms NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Neuromuscular disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Optic nerve disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Paraesthesias and dysaesthesias
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Paralysis and paresis (excl cranial nerve)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Parkinson's disease and parkinsonism
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Peripheral neuropathies NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Seizures and seizure disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 14 affected / 3881 at risk

Adverse event: Spinal cord and nerve root disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Structural brain disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Transient cerebrovascular events
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Bipolar disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Confusion and disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Deliria
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Delusional disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Depressive disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 10 affected / 3881 at risk

Adverse event: Mental disorders NEC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 3881 at risk

Adverse event: Mood alterations with manic symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Mood disorders NEC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Psychotic disorder NEC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 3881 at risk

Adverse event: Schizoaffective and schizophreniform disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Schizophrenia NEC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Substance related and addictive disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Suicidal and self-injurious behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 28 affected / 3881 at risk

Adverse event: Bladder disorders NEC
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Genital and urinary tract disorders NEC
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 3881 at risk

Adverse event: Glomerulonephritis and nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Renal failure and impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 24 affected / 3881 at risk

Adverse event: Renal lithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Renal obstructive disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Renal vascular and ischaemic conditions
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Urethral disorders NEC
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Urinary abnormalities
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Urinary tract lithiasis NEC
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Breast disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Cervix disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 3881 at risk

Adverse event: Menstruation with increased bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Ovarian and fallopian tube cysts and neoplasms
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Prostate and seminal vesicles infections and inflammations
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Prostatic neoplasms and hypertrophy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Reproductive tract disorders NEC (excl neoplasms)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Vulvovaginal disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Breathing abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 3881 at risk

Adverse event: Bronchospasm and obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 3881 at risk

Adverse event: Conditions associated with abnormal gas exchange
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Coughing and associated symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Nasal disorders NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Parenchymal lung disorders NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Pneumothorax and pleural effusions NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Pulmonary hypertensions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Pulmonary oedemas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Pulmonary thrombotic and embolic conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 3881 at risk

Adverse event: Respiratory failures (excl neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 3881 at risk

Adverse event: Respiratory tract disorders NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3881 at risk

Adverse event: Angioedemas
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Dermatitis and eczema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Dermatitis ascribed to specific agent
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Psoriatic conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Rashes, eruptions and exanthems NEC
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Skin and subcutaneous tissue ulcerations
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 3881 at risk

Adverse event: Abdominal therapeutic procedures NEC
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3881 at risk

Adverse event: Biliary tract and gallbladder therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3881 at risk

Adverse event: Cardiac valve therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 3881 at risk

Adverse event: Facial therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3881 at risk

Adverse event: Gastric therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3881 at risk

Adverse event: Hernia repairs
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 3881 at risk

Adverse event: Joint therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 3881 at risk

Adverse event: Laryngeal therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3881 at risk

Adverse event: Penile therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3881 at risk

Adverse event: Soft tissue therapeutic procedures NEC
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3881 at risk

Adverse event: Spine and spinal cord therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 3881 at risk

Adverse event: Therapeutic procedures NEC
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 3881 at risk

Adverse event: Uterine therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3881 at risk

Adverse event: Accelerated and malignant hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Aortic aneurysms and dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Aortic embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Circulatory collapse and shock
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Haemorrhages NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3881 at risk

Adverse event: Non-site specific embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Peripheral embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 3881 at risk

Adverse event: Peripheral vasoconstriction, necrosis and vascular insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Varicose veins NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Vascular hypertensive disorders NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 3881 at risk

Adverse event: Vascular hypotensive disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 3881 at risk

Adverse event: Vasculitides NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3881 at risk

Adverse event: Physical examination procedures and organ system status
Serious: no
Organ System: Investigations
Frequency: 65 affected / 3881 at risk

Adverse event: Renal function analyses
Serious: no
Organ System: Investigations
Frequency: 122 affected / 3881 at risk

Adverse event: Diabetes mellitus (incl subtypes)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 184 affected / 3881 at risk

Adverse event: General nutritional disorders NEC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 44 affected / 3881 at risk

Adverse event: Muscle pains
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 44 affected / 3881 at risk

Adverse event: Musculoskeletal and connective tissue pain and discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 43 affected / 3881 at risk

Adverse event: Vascular hypertensive disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 50 affected / 3881 at risk