Study: NCT00689936

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 532 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 532 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Hyperviscosity syndrome
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 532 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 532 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 532 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 532 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 532 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 532 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 532 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 532 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 532 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 532 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 532 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 532 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 532 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 532 at risk

Adverse event: Dilated cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 532 at risk

Adverse event: Cor pulmonale
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 532 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 532 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 532 at risk

Adverse event: Diastolic dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 532 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 532 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 532 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 532 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 532 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 532 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 532 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 532 at risk

Adverse event: Sinus arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 532 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 532 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 532 at risk

Adverse event: Tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 532 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 532 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 532 at risk

Adverse event: Thalassaemia beta
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 532 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 532 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 532 at risk

Adverse event: Blindness unilateral
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 532 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 5 affected / 532 at risk

Adverse event: Diabetic retinopathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 532 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 532 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 532 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 532 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 532 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 532 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 532 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 532 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Enterovesical fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Gastric ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 532 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 532 at risk

Adverse event: Gastrointestinal motility disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 532 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Ileus paralytic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 532 at risk

Adverse event: Inguinal hernia strangulated
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 532 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 532 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Obstruction gastric
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Oesophageal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Oral disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 532 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Rectal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Reflux gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 532 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 532 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 532 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 532 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 532 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 532 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 532 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 532 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 532 at risk

Adverse event: Inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 532 at risk

Adverse event: Influenza like illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 532 at risk

Adverse event: Injection site haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 532 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 532 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 532 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 532 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 532 at risk

Adverse event: Performance status decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 532 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 22 affected / 532 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 532 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 532 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 532 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 532 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 532 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 532 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 532 at risk

Adverse event: Hepatitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 532 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 532 at risk

Adverse event: Hypertransaminasaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 532 at risk

Adverse event: Liver disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 532 at risk

Adverse event: Amyloidosis
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 532 at risk

Adverse event: Arthritis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 532 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 532 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 532 at risk

Adverse event: Bursitis infective staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 532 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Clostridial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 532 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Diarrhoea infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 532 at risk

Adverse event: Embolic pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Endocarditis staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Enterocolitis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Epiglottitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 532 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 532 at risk

Adverse event: Fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 532 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 532 at risk

Adverse event: Infective exacerbation of chronic obstructive airways disease
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 532 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 532 at risk

Adverse event: Intervertebral discitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Klebsiella bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 532 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 532 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 532 at risk

Adverse event: Meningitis cryptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Meningococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 532 at risk

Adverse event: Oesophageal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Periodontitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Periorbital abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Pneumococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 532 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 532 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 60 affected / 532 at risk

Adverse event: Pneumonia klebsiella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Pneumonia legionella
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 532 at risk

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 532 at risk

Adverse event: Pneumonia staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 532 at risk

Adverse event: Post procedural sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Postoperative abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Pseudomembranous colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 532 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 532 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 17 affected / 532 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 532 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 532 at risk

Adverse event: Staphylococcal impetigo
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 532 at risk

Adverse event: Strongyloidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Tracheobronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 532 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 532 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 532 at risk

Adverse event: Whipple's disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 532 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 532 at risk

Adverse event: Acetabulum fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 532 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 532 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 532 at risk

Adverse event: Cervical vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 532 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 532 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 532 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 532 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 532 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 532 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 532 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 532 at risk

Adverse event: Myocardial injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 532 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 532 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 532 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 532 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 532 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 532 at risk

Adverse event: Post procedural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 532 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 532 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 532 at risk

Adverse event: Respiratory fume inhalation disorder
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 532 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 532 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 532 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 532 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 532 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 532 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 532 at risk

Adverse event: Biopsy bone marrow abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 532 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 532 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 532 at risk

Adverse event: Eastern Cooperative Oncology Group performance status worsened
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 532 at risk

Adverse event: Haemoglobin abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 532 at risk

Adverse event: Heart rate increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 532 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 532 at risk

Adverse event: Protein urine present
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 532 at risk

Adverse event: Troponin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 532 at risk

Adverse event: Troponin T increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 532 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 532 at risk

Adverse event: Cachexia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 532 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 532 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 532 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 532 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 532 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 532 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 532 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 532 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 532 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 532 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 532 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 532 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 532 at risk

Adverse event: Hypoproteinaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 532 at risk

Adverse event: Iron deficiency
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 532 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 532 at risk

Adverse event: Marasmus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 532 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 532 at risk

Adverse event: Shock hypoglycaemic
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 532 at risk

Adverse event: Tetany
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 532 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 532 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 532 at risk

Adverse event: Chondrocalcinosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Dupuytren's contracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Fibromyalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Gouty arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Gouty tophus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 532 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Muscle haemorrhage
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 532 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 532 at risk

Adverse event: Osteochondrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Osteolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Osteonecrosis of jaw
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 532 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Osteoporotic fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Polyarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Soft tissue mass
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Spinal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Synovial cyst
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Acute lymphocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 11 affected / 532 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Bowen's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Cancer pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Cardiac myxoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Colon cancer stage IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Endometrial cancer stage III
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Lentigo maligna
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Lung adenocarcinoma stage IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Lung neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Squamous cell carcinoma of lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Meningioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Metastatic malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Oral neoplasm benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Plasmacytoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 532 at risk

Adverse event: Prostate cancer recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Prostatic adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 532 at risk

Adverse event: Salivary gland cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Small intestine carcinoma metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 532 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 16 affected / 532 at risk

Adverse event: Altered state of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Brain stem infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Cauda equina syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 532 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 532 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 532 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 532 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 532 at risk

Adverse event: Dystonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Spinal cord infection
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 532 at risk

Adverse event: Guillain-Barre syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Ischaemic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 532 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Polyneuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 532 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Repetitive speech
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Speech disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 532 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 532 at risk

Adverse event: Vascular encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 532 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 532 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 532 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 532 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 532 at risk

Adverse event: Euphoric mood
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 532 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 532 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 532 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 532 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 532 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 532 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 532 at risk

Adverse event: Oliguria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 532 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 532 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 532 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 21 affected / 532 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 532 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 532 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 532 at risk

Adverse event: Prostatitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 532 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 532 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 532 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Bronchiectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 532 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 532 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 532 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 532 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 532 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 532 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 532 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 532 at risk

Adverse event: Pulmonary thrombosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 532 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 532 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 532 at risk

Adverse event: Actinic keratosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Acute febrile neutrophilic dermatosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Cutaneous vasculitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Dermatitis allergic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Exfoliative rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Hyperhidrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 532 at risk

Adverse event: Rash erythematous
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 532 at risk

Adverse event: Toxic epidermal necrolysis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 532 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 532 at risk

Adverse event: Aortic aneurysm rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 532 at risk

Adverse event: Aortic dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 532 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 19 affected / 532 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 532 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 532 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 532 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 532 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 532 at risk

Adverse event: Phlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 532 at risk

Adverse event: Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 532 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 532 at risk

Adverse event: Superficial vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 532 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 237 affected / 532 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 66 affected / 532 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 60 affected / 532 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 194 affected / 532 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 111 affected / 532 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 532 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 27 affected / 532 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 84 affected / 532 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 30 affected / 532 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 532 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 532 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 233 affected / 532 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 248 affected / 532 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 532 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 532 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 156 affected / 532 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 532 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 97 affected / 532 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 148 affected / 532 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 178 affected / 532 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 31 affected / 532 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 38 affected / 532 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 220 affected / 532 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 111 affected / 532 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 90 affected / 532 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 532 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 532 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 532 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 90 affected / 532 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 532 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 532 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 532 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 71 affected / 532 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 77 affected / 532 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 39 affected / 532 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 46 affected / 532 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 39 affected / 532 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 73 affected / 532 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 128 affected / 532 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 61 affected / 532 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 60 affected / 532 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 104 affected / 532 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 532 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 110 affected / 532 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 175 affected / 532 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 83 affected / 532 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 532 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 115 affected / 532 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 46 affected / 532 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 63 affected / 532 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 72 affected / 532 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 532 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 43 affected / 532 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 91 affected / 532 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 87 affected / 532 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 532 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 80 affected / 532 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 532 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 532 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 88 affected / 532 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 532 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 113 affected / 532 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 532 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 77 affected / 532 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 45 affected / 532 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 35 affected / 532 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 66 affected / 532 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 150 affected / 532 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 27 affected / 532 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 129 affected / 532 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 532 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 112 affected / 532 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 532 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 532 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 532 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 532 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 532 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 532 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 49 affected / 532 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 117 affected / 532 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 40 affected / 532 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 43 affected / 532 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 52 affected / 532 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 540 at risk

Adverse event: Febrile bone marrow aplasia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 540 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 540 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 540 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 540 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 540 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 540 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 540 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 540 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 540 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 540 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 540 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 540 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 540 at risk

Adverse event: Atrial thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 540 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 540 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 540 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 540 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 540 at risk

Adverse event: Cardiac flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 540 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 540 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 540 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 540 at risk

Adverse event: Hypertensive heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 540 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 540 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 540 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 540 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 540 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 540 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 540 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 540 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 540 at risk

Adverse event: Ventricular flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 540 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 540 at risk

Adverse event: Choroidal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 540 at risk

Adverse event: Conjunctival oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 540 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 540 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 540 at risk

Adverse event: Ocular hypertension
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 540 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 540 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 540 at risk

Adverse event: Abdominal wall haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 540 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 540 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Faecaloma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 540 at risk

Adverse event: Gastrointestinal necrosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Gastrointestinal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Gingival bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 540 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 540 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 540 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Subileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Tongue haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Umbilical hernia, obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 540 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 540 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 540 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 540 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 540 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 540 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 540 at risk

Adverse event: Hyperpyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 540 at risk

Adverse event: Hyperthermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 540 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 540 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 540 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 540 at risk

Adverse event: Performance status decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 540 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 540 at risk

Adverse event: Spinal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 540 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 540 at risk

Adverse event: Biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 540 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 540 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 540 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 540 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 540 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 540 at risk

Adverse event: Drug-induced liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 540 at risk

Adverse event: Abdominal wall abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Anorectal infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Arthritis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 540 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 540 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 540 at risk

Adverse event: Bronchopulmonary aspergillosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Campylobacter infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 540 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Douglas' abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Escherichia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 540 at risk

Adverse event: Fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Furuncle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 540 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Infective tenosynovitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 540 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 540 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 540 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 540 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Oesophageal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Pneumococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 48 affected / 540 at risk

Adverse event: Pneumonia escherichia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Pneumonia legionella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 540 at risk

Adverse event: Pneumonia streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Prostatic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Pseudomonal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 540 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 540 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 540 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 540 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Tuberculous pleurisy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 540 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 540 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Face injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 540 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 540 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Fractured sacrum
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 540 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Jaw fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 540 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 540 at risk

Adverse event: Sternal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Thoracic vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 540 at risk

Adverse event: Transfusion-related acute lung injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 540 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 540 at risk

Adverse event: Ejection fraction decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 540 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 540 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 540 at risk

Adverse event: Prothrombin time ratio increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 540 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 540 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 540 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 540 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 540 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 540 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 540 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 540 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 540 at risk

Adverse event: Hyperglycaemic hyperosmolar nonketotic syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 540 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 540 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 540 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 540 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 540 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 540 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 540 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 540 at risk

Adverse event: Metabolic alkalosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 540 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 540 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 540 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 540 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 540 at risk

Adverse event: Chondrocalcinosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 540 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 540 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 540 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 540 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 540 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 540 at risk

Adverse event: Myopathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 540 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 540 at risk

Adverse event: Osteolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 540 at risk

Adverse event: Osteonecrosis of jaw
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 540 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 540 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 540 at risk

Adverse event: Vertebral wedging
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 540 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 540 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Bowen's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 540 at risk

Adverse event: Carcinoid tumour in the large intestine
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Colorectal adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Colon cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Endometrial cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Gastrointestinal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Lentigo maligna
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Plasma cell leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Lung squamous cell carcinoma stage I
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Squamous cell carcinoma of lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Meningioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 540 at risk

Adverse event: Transitional cell cancer of the renal pelvis and ureter
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 540 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 540 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 540 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 540 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 540 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 540 at risk

Adverse event: Coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 540 at risk

Adverse event: Spinal cord infection
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 540 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 540 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 540 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 540 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 540 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 540 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 540 at risk

Adverse event: Paraparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 540 at risk

Adverse event: Paraplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 540 at risk

Adverse event: Parkinsonism
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 540 at risk

Adverse event: Post herpetic neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 540 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 540 at risk

Adverse event: Pyramidal tract syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 540 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 540 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 540 at risk

Adverse event: Agitated depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 540 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 540 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 540 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 540 at risk

Adverse event: Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 540 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 540 at risk

Adverse event: Loss of personal independence in daily activities
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 540 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 540 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 540 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 540 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 540 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 18 affected / 540 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 16 affected / 540 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 540 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 540 at risk

Adverse event: Urinary bladder haemorrhage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 540 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 540 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 540 at risk

Adverse event: Epididymitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 540 at risk

Adverse event: Prostatitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 540 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Bronchiectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Bronchopneumopathy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 540 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 540 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 540 at risk

Adverse event: Pulmonary arterial hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 540 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Respiratory alkalosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 540 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 540 at risk

Adverse event: Dermatitis exfoliative
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 540 at risk

Adverse event: Drug eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 540 at risk

Adverse event: Drug reaction with eosinophilia and systemic symptoms
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 540 at risk

Adverse event: Exfoliative rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 540 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 540 at risk

Adverse event: Rash macular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 540 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 540 at risk

Adverse event: Rash pruritic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 540 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 540 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 540 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 540 at risk

Adverse event: Peripheral artery aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 540 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 191 affected / 540 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 59 affected / 540 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 43 affected / 540 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 177 affected / 540 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 99 affected / 540 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 31 affected / 540 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 540 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 540 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 210 affected / 540 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 205 affected / 540 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 540 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 540 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 127 affected / 540 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 540 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 122 affected / 540 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 176 affected / 540 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 27 affected / 540 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 28 affected / 540 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 168 affected / 540 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 94 affected / 540 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 540 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 54 affected / 540 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 540 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 48 affected / 540 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 59 affected / 540 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 78 affected / 540 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 115 affected / 540 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 50 affected / 540 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 54 affected / 540 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 62 affected / 540 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 71 affected / 540 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 137 affected / 540 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 72 affected / 540 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 102 affected / 540 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 540 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 51 affected / 540 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 58 affected / 540 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 65 affected / 540 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 70 affected / 540 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 540 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 540 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 74 affected / 540 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 93 affected / 540 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 73 affected / 540 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 36 affected / 540 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 45 affected / 540 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 127 affected / 540 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 94 affected / 540 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 85 affected / 540 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 540 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 540 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 540 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 540 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 49 affected / 540 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 129 affected / 540 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 27 affected / 540 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 28 affected / 540 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 541 at risk

Adverse event: Autoimmune haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Febrile bone marrow aplasia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 541 at risk

Adverse event: Hypocoagulable state
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 541 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 541 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 541 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 541 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 541 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 541 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 541 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 541 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 541 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 541 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 541 at risk

Adverse event: Atrial thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 541 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 541 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 541 at risk

Adverse event: Bradyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 541 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 541 at risk

Adverse event: Cardiac amyloidosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 541 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 541 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 541 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 541 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 541 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 541 at risk

Adverse event: Coronary artery insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 541 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 541 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 541 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 541 at risk

Adverse event: Nodal arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 541 at risk

Adverse event: Sinoatrial block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 541 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 541 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 541 at risk

Adverse event: Left ventricle outflow tract obstruction
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 541 at risk

Adverse event: Thyroid cyst
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 541 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 541 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 541 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 541 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 541 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 541 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Enterocutaneous fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Haemorrhagic erosive gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 541 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Inguinal hernia, obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 541 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Peptic ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 541 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 541 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 541 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 541 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 541 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 541 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 541 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 541 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 541 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 541 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 541 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 541 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 541 at risk

Adverse event: Performance status decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 541 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 541 at risk

Adverse event: Spinal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 541 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 541 at risk

Adverse event: Ulcer haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 541 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 541 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 541 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 541 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 541 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Clostridial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 541 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Endocarditis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Enterococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 541 at risk

Adverse event: Hepatitis B
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 541 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 541 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Klebsiella infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Klebsiella sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 541 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 541 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 541 at risk

Adverse event: Pneumonia pseudomonal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 541 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 541 at risk

Adverse event: Oropharyngeal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 35 affected / 541 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 541 at risk

Adverse event: Pneumonia legionella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Pseudomonal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 541 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 541 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 541 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 541 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 541 at risk

Adverse event: Urinary tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 541 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 541 at risk

Adverse event: Bladder injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 541 at risk

Adverse event: Cervical vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 541 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 541 at risk

Adverse event: Face injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 541 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 541 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 541 at risk

Adverse event: Myocardial injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 541 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 541 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 541 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 541 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 541 at risk

Adverse event: Medication error
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 541 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 541 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 541 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 541 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 541 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 541 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 541 at risk

Adverse event: Sternal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 541 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 541 at risk

Adverse event: Traumatic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 541 at risk

Adverse event: Ulna fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 541 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 541 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 541 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 541 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 541 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 541 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 541 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 541 at risk

Adverse event: Food intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 541 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 541 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 541 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 541 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 541 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 541 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 541 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 541 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 541 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 541 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 541 at risk

Adverse event: Bone lesion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 541 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 541 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 541 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 541 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 541 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 541 at risk

Adverse event: Osteolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 541 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 541 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 541 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 541 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 541 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 541 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 541 at risk

Adverse event: Breast cancer in situ
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 541 at risk

Adverse event: Plasma cell leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 541 at risk

Adverse event: Lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 541 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 541 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 541 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 541 at risk

Adverse event: Neoplasm swelling
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 541 at risk

Adverse event: Oesophageal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 541 at risk

Adverse event: Plasmacytoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 541 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 541 at risk

Adverse event: Tumour flare
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 541 at risk

Adverse event: Brain stem infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 541 at risk

Adverse event: Coordination abnormal
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 541 at risk

Adverse event: Dystonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Motor neurone disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Peripheral sensorimotor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 541 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Spinal cord compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 541 at risk

Adverse event: Transient global amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 541 at risk

Adverse event: Trigeminal neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 541 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 541 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 541 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 541 at risk

Adverse event: Depressed mood
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 541 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 541 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 541 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 541 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 541 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 14 affected / 541 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 10 affected / 541 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 541 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 541 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 541 at risk

Adverse event: Genital prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 541 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 541 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 541 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 541 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 541 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 541 at risk

Adverse event: Pulmonary alveolar haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 541 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Pulmonary infarction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 541 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 541 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 541 at risk

Adverse event: Actinic keratosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 541 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 541 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 541 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 541 at risk

Adverse event: Arterial haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 541 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 541 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 541 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 541 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 541 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 541 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 541 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 541 at risk

Adverse event: Phlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 541 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 541 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 541 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 219 affected / 541 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 92 affected / 541 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 71 affected / 541 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 325 affected / 541 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 132 affected / 541 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 35 affected / 541 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 541 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 541 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 282 affected / 541 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 86 affected / 541 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 62 affected / 541 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 541 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 163 affected / 541 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 104 affected / 541 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 123 affected / 541 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 153 affected / 541 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 32 affected / 541 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 213 affected / 541 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 69 affected / 541 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 541 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 541 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 541 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 541 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 47 affected / 541 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 72 affected / 541 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 30 affected / 541 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 38 affected / 541 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 67 affected / 541 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 115 affected / 541 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 58 affected / 541 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 61 affected / 541 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 541 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 39 affected / 541 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 36 affected / 541 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 60 affected / 541 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 114 affected / 541 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 541 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 40 affected / 541 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 62 affected / 541 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 102 affected / 541 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 191 affected / 541 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 541 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 100 affected / 541 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 41 affected / 541 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 30 affected / 541 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 53 affected / 541 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 67 affected / 541 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 110 affected / 541 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 541 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 91 affected / 541 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 35 affected / 541 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 35 affected / 541 at risk