Study: NCT02287233

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Nosocomial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Parainfluenzae virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 8 at risk

Adverse event: Pneumonia klebsiella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Serratia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Vascular device infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Traumatic pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: White blood cell count increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 8 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Psychotic disorder due to a general medical condition
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 8 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 8 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 8 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 8 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 8 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 8 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Lip ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Mouth haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

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

Adverse event: Odynophagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Paraesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 8 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Device related thrombosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 8 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 8 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Bronchopulmonary aspergillosis allergic
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Sialoadenitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Sunburn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Tooth fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Heart rate irregular
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Liver function test increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Specific gravity urine decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 8 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 8 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 8 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 8 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 8 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Chondrocalcinosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Limb mass
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 8 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Cerebral microangiopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 8 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 8 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hallucination, visual
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Procedural anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 8 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Pleuritic pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 8 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 8 at risk

Adverse event: Macroangiopathy
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 10 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 10 at risk

Adverse event: Bronchopulmonary aspergillosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Candida pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Infectious pleural effusion
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 10 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypofibrinogenaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 10 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 10 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 10 at risk

Adverse event: Erythema of eyelid
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Gastrointestinal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 10 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Tongue haematoma
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Trichoglossia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Catheter site inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Escherichia urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 10 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Periorbital haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Prothrombin time prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 10 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypochloraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 10 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 10 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Flat affect
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Mood altered
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 10 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nail discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Stasis dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 10 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 74 at risk

Adverse event: Haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 74 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 74 at risk

Adverse event: Atrioventricular block first degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 74 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 74 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 74 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 74 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 74 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 74 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 74 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Diverticulum intestinal haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 74 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 74 at risk

Adverse event: Device related thrombosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 74 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 74 at risk

Adverse event: Gait disturbance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 74 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 74 at risk

Adverse event: Hyperpyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 74 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 74 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 74 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 74 at risk

Adverse event: Acute hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 74 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 74 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 74 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 74 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 74 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Bronchopulmonary aspergillosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 74 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 74 at risk

Adverse event: Escherichia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 74 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 74 at risk

Adverse event: Large intestine infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 74 at risk

Adverse event: Pulmonary sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Respiratory tract infection fungal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 74 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Upper respiratory tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 74 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Vascular device infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 74 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 74 at risk

Adverse event: Intentional overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 74 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 74 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 74 at risk

Adverse event: Splenic rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 74 at risk

Adverse event: Amylase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 74 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 74 at risk

Adverse event: Troponin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 74 at risk

Adverse event: White blood cell count increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 74 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 74 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 74 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 74 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Bursitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 74 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 74 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 74 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 74 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 74 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 74 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 74 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 74 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 74 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 74 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 74 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Pulmonary alveolar haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 74 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 74 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 74 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 74 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 74 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 74 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 74 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 74 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 74 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 74 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 74 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 74 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 74 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 74 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 74 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 74 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 74 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 74 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 74 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 74 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 74 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 74 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 74 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 74 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 74 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 74 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Mouth haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 74 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 74 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 74 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 74 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 74 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 74 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 74 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 6 affected / 74 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 74 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 74 at risk

Adverse event: Device related thrombosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 74 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 28 affected / 74 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 6 affected / 74 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 8 affected / 74 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 74 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 13 affected / 74 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 74 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 74 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 74 at risk

Adverse event: Clostridium difficile infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 74 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 74 at risk

Adverse event: Escherichia urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 74 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 74 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 74 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 74 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 74 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 74 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 74 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 74 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 74 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 74 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 8 affected / 74 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 74 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 74 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 74 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 74 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 74 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 74 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 74 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 74 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 74 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 74 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 74 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 74 at risk

Adverse event: Prothrombin time prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 74 at risk

Adverse event: Troponin increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 74 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 74 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 74 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 28 affected / 74 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 74 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 74 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 74 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 74 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 74 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 74 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 74 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 74 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 74 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 74 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 74 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 74 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 74 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 74 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 74 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 74 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Chondrocalcinosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 74 at risk

Adverse event: Limb mass
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 74 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 74 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 74 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 74 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 74 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 74 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 74 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 74 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 74 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 74 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 74 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 74 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 74 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 74 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 74 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 74 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 74 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 74 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 74 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 74 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 74 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 74 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 74 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 74 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 74 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 74 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 74 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 74 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 74 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 74 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 74 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 74 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 74 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 74 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 74 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 74 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 74 at risk

Adverse event: Stasis dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 74 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 74 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 74 at risk