Study: NCT03976362

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 851 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 851 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 851 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 851 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 851 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 851 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 851 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 851 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 851 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 851 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 851 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 851 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 851 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 851 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 851 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 851 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 851 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 851 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 851 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 851 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 851 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 851 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 851 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 851 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 851 at risk

Adverse event: Enterocolitis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 851 at risk

Adverse event: Lung abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 851 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 36 affected / 851 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 851 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 851 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 851 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 851 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 851 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 851 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 851 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 851 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 851 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 851 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 851 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 851 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 851 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 851 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 851 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 851 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 851 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 851 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 851 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 851 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 851 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 851 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 851 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 851 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 851 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 851 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 851 at risk

Adverse event: Superior vena cava syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 851 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 851 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 851 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 851 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 851 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 851 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 851 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 851 at risk

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 851 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 851 at risk

Adverse event: Hypophysitis
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 851 at risk

Adverse event: Inappropriate antidiuretic hormone secretion
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 851 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 851 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 851 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 851 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 851 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 851 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 851 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 851 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 851 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 851 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 851 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 851 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 851 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 851 at risk

Adverse event: Autoimmune hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 851 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 851 at risk

Adverse event: Drug-induced liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 851 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 851 at risk

Adverse event: Hepatotoxicity
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 851 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 851 at risk

Adverse event: Immune-mediated hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 851 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 851 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 851 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 851 at risk

Adverse event: Liver abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 851 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 851 at risk

Adverse event: Mediastinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 851 at risk

Adverse event: Meningitis cryptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 851 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 851 at risk

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 851 at risk

Adverse event: Rash pustular
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 851 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 851 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 851 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 851 at risk

Adverse event: Eastern Cooperative Oncology Group performance status worsened
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 851 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 851 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 851 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 851 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 851 at risk

Adverse event: Steroid diabetes
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 851 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 851 at risk

Adverse event: Osteoporotic fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 851 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 851 at risk

Adverse event: Cancer pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 851 at risk

Adverse event: Rectal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 851 at risk

Adverse event: Tumour haemorrhage
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 851 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 851 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 851 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 851 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 851 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 851 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 851 at risk

Adverse event: Stupor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 851 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 851 at risk

Adverse event: Toxic neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 851 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 851 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 851 at risk

Adverse event: Autoimmune nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 851 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 851 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 851 at risk

Adverse event: Tubulointerstitial nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 851 at risk

Adverse event: Orchitis noninfective
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 851 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 851 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 851 at risk

Adverse event: Bronchial haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 851 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 851 at risk

Adverse event: Hiccups
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 851 at risk

Adverse event: Sputum increased
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 851 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 851 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 851 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 851 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 851 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 851 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 851 at risk

Adverse event: Subclavian artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 851 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 369 affected / 851 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 168 affected / 851 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 851 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 279 affected / 851 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 200 affected / 851 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 25 affected / 851 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 147 affected / 851 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 112 affected / 851 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 215 affected / 851 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 851 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 115 affected / 851 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 105 affected / 851 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 74 affected / 851 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 851 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 851 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 54 affected / 851 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 39 affected / 851 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 38 affected / 851 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 31 affected / 851 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 36 affected / 851 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 140 affected / 851 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 851 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 31 affected / 851 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 41 affected / 851 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 65 affected / 851 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 851 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 75 affected / 851 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 851 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 851 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 851 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 851 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 851 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 55 affected / 851 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 63 affected / 851 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 851 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 27 affected / 851 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 851 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 851 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 851 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 851 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 851 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 851 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 851 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 851 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 851 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 120 affected / 851 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 60 affected / 851 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 62 affected / 851 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 43 affected / 851 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 851 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 279 affected / 851 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 851 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 294 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 294 at risk

Adverse event: Haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 294 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 294 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 294 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 294 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 294 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 294 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 294 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 294 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 294 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 294 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Immune-mediated enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 294 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 294 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 294 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 294 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 294 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 294 at risk

Adverse event: Cholangitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 294 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 294 at risk

Adverse event: Hypertransaminasaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 294 at risk

Adverse event: Liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 294 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 294 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 294 at risk

Adverse event: Carbuncle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 294 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 294 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 294 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 294 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 294 at risk

Adverse event: Shoulder fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 294 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 294 at risk

Adverse event: Traumatic lung injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 294 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 294 at risk

Adverse event: Troponin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 294 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 294 at risk

Adverse event: Cervical spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 294 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 294 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 294 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 294 at risk

Adverse event: Tumour associated fever
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 294 at risk

Adverse event: Cerebral haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 294 at risk

Adverse event: Facial nerve disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 294 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 294 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 294 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 294 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 294 at risk

Adverse event: Nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 294 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 294 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 294 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 294 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 294 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 294 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Superior vena cava syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 294 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 130 affected / 294 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 44 affected / 294 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 294 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 57 affected / 294 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 56 affected / 294 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 23 affected / 294 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 294 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 294 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 69 affected / 294 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 294 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 42 affected / 294 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 32 affected / 294 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 294 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 294 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 294 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 25 affected / 294 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 25 affected / 294 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 21 affected / 294 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 26 affected / 294 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 294 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 54 affected / 294 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 294 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 294 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 294 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 294 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 294 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 294 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 294 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 294 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 294 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 294 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 294 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 294 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 294 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 294 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 4 affected / 294 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 294 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 294 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 294 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 294 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 294 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 294 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 294 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 294 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 294 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 294 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 294 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 294 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 292 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 292 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 292 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 292 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 292 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 292 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 292 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 292 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 292 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 292 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 292 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Immune-mediated enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 292 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 292 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 292 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 292 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 292 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 292 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 292 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 292 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 292 at risk

Adverse event: Enterocolitis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 292 at risk

Adverse event: Hepatitis C
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 292 at risk

Adverse event: Herpes zoster disseminated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 292 at risk

Adverse event: Lung abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 292 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 292 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 292 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 292 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 292 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 292 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 292 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 292 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 292 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 292 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 292 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 292 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 292 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 292 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 292 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 292 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 292 at risk

Adverse event: Adenocarcinoma gastric
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 292 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 292 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 292 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 292 at risk

Adverse event: Myoclonus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 292 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 292 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 292 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 292 at risk

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 292 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 292 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 292 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 292 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 292 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Drug eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 292 at risk

Adverse event: Eczema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 292 at risk

Adverse event: Pemphigoid
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 292 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 292 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 292 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 292 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 45 affected / 292 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 292 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 292 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 292 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 292 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 34 affected / 292 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 292 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 292 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 292 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 292 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 37 affected / 292 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 40 affected / 292 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 292 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 292 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 292 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 29 affected / 292 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 27 affected / 292 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 292 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 292 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 292 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 47 affected / 292 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 292 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 292 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 292 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 292 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 292 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 292 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 292 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 292 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 292 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 292 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 292 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 292 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 292 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 292 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 292 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 292 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 292 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 292 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 292 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 292 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 292 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 292 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 292 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 292 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 292 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 292 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 292 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 292 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 7 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Lower respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk