Study: NCT00548548

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 386 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 386 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 386 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 386 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 386 at risk

Adverse event: Gastric perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 386 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 386 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 386 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Gastrointestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 386 at risk

Adverse event: Gastrointestinal toxicity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Obstruction gastric
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 386 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 386 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Enterocutaneous fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Gastric stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Gastrointestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Ileal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Large intestinal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Oesophageal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 386 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 386 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 386 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 386 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 386 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 386 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 386 at risk

Adverse event: Microangiopathic haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 386 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 386 at risk

Adverse event: Splenic infarction
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 386 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 386 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 386 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 386 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 386 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 386 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 386 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 386 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 386 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 386 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 386 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 386 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 386 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 386 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 386 at risk

Adverse event: Osteomyelitis chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 386 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 386 at risk

Adverse event: Tooth infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 386 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 386 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 386 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 386 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 386 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 386 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 386 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 386 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 386 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 386 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 386 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Pharyngeal inflammation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 386 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 386 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 386 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 386 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 386 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 386 at risk

Adverse event: Jugular vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 386 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 386 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 386 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 386 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 386 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 386 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 386 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 386 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 386 at risk

Adverse event: Posterior reversible encephalopathy syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 386 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 386 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 386 at risk

Adverse event: Nervous system disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 386 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 386 at risk

Adverse event: Pneumothorax traumatic
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 386 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 386 at risk

Adverse event: Device occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 386 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 386 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 386 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 386 at risk

Adverse event: Liver disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 386 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 386 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 386 at risk

Adverse event: Alcohol abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 386 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 386 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 386 at risk

Adverse event: Restlessness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 386 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 386 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 386 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 386 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 386 at risk

Adverse event: Tumour haemorrhage
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 386 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 386 at risk

Adverse event: Tumour necrosis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 386 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 386 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 386 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 386 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 386 at risk

Adverse event: Retinopathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 386 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 386 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 386 at risk

Adverse event: Device occlusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 386 at risk

Adverse event: Stent malfunction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 386 at risk

Adverse event: Thrombosis in device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 386 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 386 at risk

Adverse event: Stoma site haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 386 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 264 affected / 386 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 192 affected / 386 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 180 affected / 386 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 141 affected / 386 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 111 affected / 386 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 82 affected / 386 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 386 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 386 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 386 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 250 affected / 386 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 83 affected / 386 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 70 affected / 386 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 386 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 183 affected / 386 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 94 affected / 386 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 56 affected / 386 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 386 at risk

Adverse event: Pigmentation disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 386 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 386 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 157 affected / 386 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 77 affected / 386 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 54 affected / 386 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 53 affected / 386 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 30 affected / 386 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 386 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 386 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 42 affected / 386 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 42 affected / 386 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 386 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 204 affected / 386 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 52 affected / 386 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 64 affected / 386 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 386 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 386 at risk

Adverse event: Creatinine renal clearance decreased
Serious: no
Organ System: Investigations
Frequency: 49 affected / 386 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 44 affected / 386 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 84 affected / 386 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 386 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 386 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 28 affected / 386 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 24 affected / 386 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 43 affected / 386 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 386 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 386 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 386 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 386 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 386 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 381 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 381 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 381 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 381 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 381 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 381 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 381 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 381 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 381 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 381 at risk

Adverse event: Gastrointestinal toxicity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 381 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 381 at risk

Adverse event: Obstruction gastric
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 381 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 381 at risk

Adverse event: Acute abdomen
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 381 at risk

Adverse event: Duodenal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 381 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 381 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 381 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 381 at risk

Adverse event: Mallory-Weiss syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 381 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 381 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 381 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 381 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 381 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 381 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 381 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 381 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 381 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 381 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 381 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 381 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 381 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 381 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 381 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 381 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 381 at risk

Adverse event: Neutropenic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 381 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 381 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 381 at risk

Adverse event: Bacillus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 381 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 381 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 381 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 381 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 381 at risk

Adverse event: Lung abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 381 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 381 at risk

Adverse event: Peritonitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 381 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 381 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 381 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 381 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 381 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 381 at risk

Adverse event: Device related thrombosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 381 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 381 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 381 at risk

Adverse event: Hyperpyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 381 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 381 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 381 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 381 at risk

Adverse event: Pulmonary artery thrombosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 381 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 381 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 381 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 381 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 381 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 381 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 381 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 381 at risk

Adverse event: Vasospasm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 381 at risk

Adverse event: Peripheral vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 381 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 381 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 381 at risk

Adverse event: Nephropathy toxic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 381 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 381 at risk

Adverse event: Renal salt-wasting syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 381 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 381 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 381 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 381 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 381 at risk

Adverse event: Afferent loop syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 381 at risk

Adverse event: Oesophageal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 381 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 381 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 381 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 381 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 381 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 381 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 381 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 381 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 381 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 381 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 381 at risk

Adverse event: Tumour haemorrhage
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 381 at risk

Adverse event: Tumour perforation
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 381 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 381 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 381 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 381 at risk

Adverse event: Pemphigoid
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 381 at risk

Adverse event: Blood potassium decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 381 at risk

Adverse event: Blood sodium decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 381 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 381 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 381 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 381 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 381 at risk

Adverse event: Bile duct stenosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 381 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 381 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 248 affected / 381 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 188 affected / 381 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 142 affected / 381 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 124 affected / 381 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 88 affected / 381 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 381 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 381 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 381 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 381 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 221 affected / 381 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 111 affected / 381 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 67 affected / 381 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 381 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 124 affected / 381 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 87 affected / 381 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 53 affected / 381 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 381 at risk

Adverse event: Pigmentation disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 381 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 381 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 145 affected / 381 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 64 affected / 381 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 51 affected / 381 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 32 affected / 381 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 37 affected / 381 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 50 affected / 381 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 381 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 381 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 381 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 381 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 175 affected / 381 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 56 affected / 381 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 381 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 381 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 381 at risk

Adverse event: Creatinine renal clearance decreased
Serious: no
Organ System: Investigations
Frequency: 63 affected / 381 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 43 affected / 381 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 51 affected / 381 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 381 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 381 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 20 affected / 381 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 381 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 37 affected / 381 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 381 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 381 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 381 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 381 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 381 at risk