Study: NCT03126435

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 102 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 102 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 102 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 102 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 102 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 102 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 102 at risk

Adverse event: Colitis erosive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 102 at risk

Adverse event: Duodenal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Erosive duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 102 at risk

Adverse event: Mechanical ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Oesophageal varices haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 102 at risk

Adverse event: Subileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 102 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 102 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 102 at risk

Adverse event: Biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 102 at risk

Adverse event: Hepatitis toxic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 102 at risk

Adverse event: Malignant biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 102 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Biliary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Empyema
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Enterococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Febrile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Liver abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 102 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 102 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 102 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Vascular access complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 102 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 102 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 102 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 102 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Metastases to bone
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 102 at risk

Adverse event: Tumour associated fever
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 102 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 102 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 102 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 102 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 102 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 102 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 102 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 102 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 41 affected / 102 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 102 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 102 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 102 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 102 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 102 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 102 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 102 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 102 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 102 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 102 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 102 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 19 affected / 102 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 18 affected / 102 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 18 affected / 102 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 35 affected / 102 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 102 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 102 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 102 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 102 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 102 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 102 at risk

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 102 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 102 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Duodenal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 102 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Gastric ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Obstruction gastric
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Subileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 102 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Influenza like illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Bile duct stenosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 102 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 102 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 102 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 102 at risk

Adverse event: Jaundice cholestatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 102 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Biliary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Liver abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Peritonitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 102 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 102 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 102 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 102 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 102 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 102 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 102 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 102 at risk

Adverse event: Subclavian vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 102 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 42 affected / 102 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 21 affected / 102 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 102 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 102 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 102 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 102 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 102 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 102 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 102 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 102 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 102 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 102 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 102 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 102 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 6 affected / 102 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 102 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 102 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 102 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 102 at risk