Study: NCT01373164

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Malignant ascites
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 5 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 5 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 5 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 5 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 5 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: Blood calcium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 5 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 5 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 5 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 5 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 4 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Early satiety
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 4 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Brain natriuretic peptide increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Neurotoxicity
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 4 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 5 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 5 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 5 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Jaundice
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Ejection fraction decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 5 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 5 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 103 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 103 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 103 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 103 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 103 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Duodenal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Femoral hernia incarcerated
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Ileus paralytic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 103 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 103 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 103 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 103 at risk

Adverse event: Bile duct stenosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 103 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 103 at risk

Adverse event: Cholangitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Jaundice cholestatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 103 at risk

Adverse event: Biliary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Liver abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Peritonitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 103 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 103 at risk

Adverse event: Gastrointestinal stoma complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 103 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 103 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 103 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 103 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 103 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 103 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 103 at risk

Adverse event: Tumour pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 103 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Device occlusion
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 103 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 103 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Ureteric stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 103 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Shock haemorrhagic
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 103 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 44 affected / 103 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 103 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 103 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 103 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 103 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 103 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 103 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 103 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 103 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 103 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 103 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 103 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 103 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 103 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 36 affected / 103 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 10 affected / 103 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 103 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 103 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 23 affected / 103 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 38 affected / 103 at risk

Adverse event: Jaundice
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 103 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 103 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 103 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 103 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 103 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 103 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 103 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 103 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 103 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 103 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 103 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 30 affected / 103 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 103 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 103 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 103 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 103 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 103 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 103 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 103 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 103 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 103 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 103 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 103 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 103 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 103 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 103 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 103 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 103 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 103 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 103 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 103 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 103 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 103 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 103 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 103 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 103 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 103 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 103 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 103 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 103 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Duodenal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 52 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Obstruction gastric
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 52 at risk

Adverse event: Biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Bile duct stenosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 52 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hepatocellular injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Catheter site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 52 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 52 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Disturbance in attention
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 52 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 52 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pancreatic pseudocyst drainage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 52 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 52 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 52 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 52 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 52 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 52 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 52 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 52 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 52 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 52 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 52 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 52 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 52 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 52 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 52 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 17 affected / 52 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 52 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 52 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 4 affected / 52 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 12 affected / 52 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 52 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 52 at risk

Adverse event: Jaundice
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 52 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 52 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 52 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 52 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 52 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 52 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 52 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 52 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 52 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 52 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 52 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 52 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 52 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 52 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 52 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 52 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 52 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 52 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 52 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 52 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 52 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 52 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 52 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 52 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 52 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 52 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 52 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 52 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 52 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 52 at risk