Study: NCT02744092

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3+
Frequency: 15 affected / 330 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3+
Frequency: 3 affected / 330 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Eye disorders - Other, specify
Serious: yes
Organ System: Eye disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 3 affected / 330 at risk

Adverse event: Colonic
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 3 affected / 330 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 2 affected / 330 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 3 affected / 330 at risk

Adverse event: Obstruction gastric
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 4 affected / 330 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 3 affected / 330 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 2 affected / 330 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 8 affected / 330 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 34 affected / 330 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 2 affected / 330 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 4 affected / 330 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 2 affected / 330 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 2 affected / 330 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 22 affected / 330 at risk

Adverse event: Abdominal infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 6 affected / 330 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 3 affected / 330 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 3 affected / 330 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grade 3+
Frequency: 2 affected / 330 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Notes: Grade 3+
Frequency: 2 affected / 330 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 3+
Frequency: 3 affected / 330 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3+
Frequency: 6 affected / 330 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3+
Frequency: 2 affected / 330 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3+
Frequency: 3 affected / 330 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3+
Frequency: 2 affected / 330 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Grade 3+
Frequency: 10 affected / 330 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 2 affected / 330 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 5 affected / 330 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3+
Frequency: 3 affected / 330 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3+
Frequency: 4 affected / 330 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3+
Frequency: 2 affected / 330 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 3 affected / 330 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 3 affected / 330 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 2 affected / 330 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Surgical and medical procedures - Other, specify
Serious: yes
Organ System: Surgical and medical procedures
Notes: Grade 3+
Frequency: 2 affected / 330 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3+
Frequency: 14 affected / 330 at risk

Adverse event: Embolism arterial
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3+
Frequency: 1 affected / 330 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2
Frequency: 3 affected / 330 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2
Frequency: 2 affected / 330 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 330 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 1 or 2
Frequency: 5 affected / 330 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 330 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 330 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 330 at risk

Adverse event: Laryngeal haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 330 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 or 2
Frequency: 5 affected / 330 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3+
Frequency: 10 affected / 308 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3+
Frequency: 2 affected / 308 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3+
Frequency: 2 affected / 308 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3+
Frequency: 2 affected / 308 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3+
Frequency: 2 affected / 308 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 2 affected / 308 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Lower GI hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 2 affected / 308 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 4 affected / 308 at risk

Adverse event: Obstruction gastric
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 3 affected / 308 at risk

Adverse event: Proctalgia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 2 affected / 308 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 4 affected / 308 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 3 affected / 308 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 33 affected / 308 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 4 affected / 308 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 7 affected / 308 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Grade 3+
Frequency: 2 affected / 308 at risk

Adverse event: Hepatobiliary disorders - Other, specify
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Biliary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Enterocolitis infectious
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 5 affected / 308 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 5 affected / 308 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grade 3+
Frequency: 2 affected / 308 at risk

Adverse event: Stoma site haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: yes
Organ System: Investigations
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: INR incresed
Serious: yes
Organ System: Investigations
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 3+
Frequency: 5 affected / 308 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3+
Frequency: 2 affected / 308 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Grade 3+
Frequency: 13 affected / 308 at risk

Adverse event: Tumour haemorrhage
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Facial paresis
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 2 affected / 308 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Spinal cord compression
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3+
Frequency: 3 affected / 308 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3+
Frequency: 2 affected / 308 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3+
Frequency: 2 affected / 308 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Vulvovaginal inflammation
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 4 affected / 308 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 3 affected / 308 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 8 affected / 308 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Surgical and medical procedures - Other, specify
Serious: yes
Organ System: Surgical and medical procedures
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3+
Frequency: 4 affected / 308 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3+
Frequency: 16 affected / 308 at risk

Adverse event: Vascular disorders - Other, specify
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3+
Frequency: 1 affected / 308 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 or 2
Frequency: 2 affected / 308 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 308 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 or 2
Frequency: 5 affected / 308 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2
Frequency: 4 affected / 308 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 1 or 2
Frequency: 2 affected / 308 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 308 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 308 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 308 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 308 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 or 2
Frequency: 11 affected / 308 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3+
Frequency: 7 affected / 107 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3+
Frequency: 2 affected / 107 at risk

Adverse event: Cardiac disorders - Other, specify
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 2 affected / 107 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Lower GI hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Obstruction gastric
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 2 affected / 107 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 3 affected / 107 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 5 affected / 107 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 3 affected / 107 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 2 affected / 107 at risk

Adverse event: Hepatobiliary disorders - Other, specify
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Abdominal infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Enterocolitis infectious
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 6 affected / 107 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 2 affected / 107 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 3 affected / 107 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grade 3+
Frequency: 4 affected / 107 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Investigations
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 3+
Frequency: 2 affected / 107 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Soft tissue necrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Grade 3+
Frequency: 12 affected / 107 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 4 affected / 107 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 3 affected / 107 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3+
Frequency: 1 affected / 107 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3+
Frequency: 5 affected / 107 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 107 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 107 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 107 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 107 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2
Frequency: 2 affected / 107 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 107 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 107 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 1 or 2
Frequency: 3 affected / 107 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1 or 2
Frequency: 1 affected / 107 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 107 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 107 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 107 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 107 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 107 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 or 2
Frequency: 2 affected / 107 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3+
Frequency: 3 affected / 30 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3+
Frequency: 3 affected / 30 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Arthritis infective
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3+
Frequency: 2 affected / 30 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Grade 3+
Frequency: 5 affected / 30 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3+
Frequency: 2 affected / 30 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 2 affected / 30 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3+
Frequency: 1 affected / 30 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 or 2
Frequency: 2 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2
Frequency: 2 affected / 30 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 30 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 30 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 30 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 30 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 30 at risk

Adverse event: Laryngeal haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 30 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 or 2
Frequency: 1 affected / 30 at risk