Study: NCT01556490

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 274 at risk

Adverse event: Bicytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Microcytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 274 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 274 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 274 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 274 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 274 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 274 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 274 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 274 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Gastric ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 274 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 274 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 274 at risk

Adverse event: Oesophageal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 274 at risk

Adverse event: Oesophageal varices haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 274 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Haemoperitoneum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 274 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 274 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 274 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 274 at risk

Adverse event: Hyperthermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 274 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 274 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 274 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 274 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 274 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 274 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 274 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 274 at risk

Adverse event: Hepatic haemorrhage
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 274 at risk

Adverse event: Hepatorenal syndrome
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 274 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 274 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 274 at risk

Adverse event: Abdominal wall abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 274 at risk

Adverse event: Abscess intestinal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 274 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 274 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 274 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 274 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 274 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 274 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 274 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 274 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 274 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 274 at risk

Adverse event: Post embolisation syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 274 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 274 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 274 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 274 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 274 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 274 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 274 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 274 at risk

Adverse event: Cancer pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 274 at risk

Adverse event: Lip and/or oral cavity cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 274 at risk

Adverse event: Liver carcinoma ruptured
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 274 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 274 at risk

Adverse event: Tumour pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 274 at risk

Adverse event: Cerebral haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 274 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 274 at risk

Adverse event: Ischaemic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 274 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 274 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 274 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Palmar-plantar erythrodysaesthesia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 274 at risk

Adverse event: Psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 274 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 274 at risk

Adverse event: Therapeutic embolisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 274 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 274 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 274 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 274 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 274 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 274 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 274 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 274 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 274 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 274 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 140 affected / 274 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 274 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 274 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 274 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 274 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 84 affected / 274 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 32 affected / 274 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 274 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 17 affected / 274 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 274 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 274 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 274 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 43 affected / 274 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 87 affected / 274 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 274 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 274 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 274 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 274 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 274 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 274 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 274 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 274 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 274 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 274 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 274 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 274 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 274 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 274 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 61 affected / 274 at risk

Adverse event: Hypercoagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 207 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 207 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 207 at risk

Adverse event: Hyperparathyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 207 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 207 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 207 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Abdominal wall haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 207 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 207 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Intra-abdominal fluid collection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Oesophageal varices haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 207 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 207 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 207 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 207 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 207 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 207 at risk

Adverse event: Ulcer haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 207 at risk

Adverse event: Autoimmune hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 207 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 207 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 207 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 207 at risk

Adverse event: Jaundice cholestatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 207 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Brain abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Endocarditis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Liver abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Peritonitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 207 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 207 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 207 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 207 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 207 at risk

Adverse event: Radiation hepatitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 207 at risk

Adverse event: Thoracic vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 207 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 207 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 207 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 207 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 207 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 207 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 207 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 207 at risk

Adverse event: Cervical spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 207 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 207 at risk

Adverse event: Head and neck cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 207 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 207 at risk

Adverse event: Metastases to bone
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 207 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 207 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 207 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 207 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 207 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 207 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 207 at risk

Adverse event: Posterior reversible encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 207 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 207 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 207 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 207 at risk

Adverse event: Hepatic hydrothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 207 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 207 at risk

Adverse event: Palmar-plantar erythrodysaesthesia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 207 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 207 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 207 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 207 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 207 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 207 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 207 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 207 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 207 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 62 affected / 207 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 207 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 207 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 207 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 42 affected / 207 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 69 affected / 207 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 26 affected / 207 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 207 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 207 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 15 affected / 207 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 207 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 207 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 30 affected / 207 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 64 affected / 207 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 207 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 207 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 207 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 207 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 207 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 207 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 207 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 207 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 207 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 207 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 207 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 207 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 207 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 207 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 28 affected / 207 at risk