Study: NCT03840902

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: 4 affected / 74 at risk

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

Adverse event: Myelosuppression
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: 2 affected / 74 at risk

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

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 74 at risk

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

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

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

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

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

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 74 at risk

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

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

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

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

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 74 at risk

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

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

Adverse event: Immune-mediated hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
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: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

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

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

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

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

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

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

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

Adverse event: Radiation oesophagitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 74 at risk

Adverse event: Radiation pneumonitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 74 at risk

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

Adverse event: Glomerular filtration rate decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 74 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 74 at risk

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

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

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

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

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

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue 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: Bowen's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 74 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 74 at risk

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

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

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

Adverse event: Bronchial haemorrhage
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: 1 affected / 74 at risk

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

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

Adverse event: Interstitial lung disease
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: 5 affected / 74 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 74 at risk

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

Adverse event: Erythema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Pemphigoid
Serious: yes
Organ System: Skin and subcutaneous tissue 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: 38 affected / 74 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 74 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 74 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 74 at risk

Adverse event: Pancytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 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: 2 affected / 74 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 74 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 74 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 74 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 74 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 74 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 74 at risk

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

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

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

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

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 74 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 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: 5 affected / 74 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 74 at risk

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

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

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

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

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

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 74 at risk

Adverse event: Odynophagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 74 at risk

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

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 74 at risk

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

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

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 74 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 74 at risk

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

Adverse event: Catheter site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 74 at risk

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

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 74 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 74 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 74 at risk

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

Adverse event: Infusion site extravasation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 74 at risk

Adverse event: Infusion site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 74 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 5 affected / 74 at risk

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

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 5 affected / 74 at risk

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

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 74 at risk

Adverse event: Bile duct stone
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 74 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 74 at risk

Adverse event: Immune-mediated hepatitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 74 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 74 at risk

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

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

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

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 74 at risk

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

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 74 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

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

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

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 74 at risk

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

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

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

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

Adverse event: Oesophageal infection
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: 1 affected / 74 at risk

Adverse event: Peri-implantitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

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

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

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 74 at risk

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

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 74 at risk

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

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

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

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 74 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

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

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

Adverse event: Radiation oesophagitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 74 at risk

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

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 74 at risk

Adverse event: Compression fracture
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: 1 affected / 74 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 74 at risk

Adverse event: Alpha hydroxybutyrate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 74 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 74 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 74 at risk

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

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

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

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

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

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

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

Adverse event: Blood thyroid stimulating hormone increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 74 at risk

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

Adverse event: Brain natriuretic peptide increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 74 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 74 at risk

Adverse event: Fibrin D dimer increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 74 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 74 at risk

Adverse event: Glomerular filtration rate decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 74 at risk

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

Adverse event: Lung diffusion test decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 74 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 74 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 74 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 74 at risk

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

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

Adverse event: Pulmonary function test decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 74 at risk

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

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 74 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 24 affected / 74 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 74 at risk

Adverse event: Cachexia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 74 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 74 at risk

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

Adverse event: Electrolyte imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 74 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 74 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 74 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 74 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 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: 4 affected / 74 at risk

Adverse event: Hypochloraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 74 at risk

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

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

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 74 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 74 at risk

Adverse event: Malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 74 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 74 at risk

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 74 at risk

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

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

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

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

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 74 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 74 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 74 at risk

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

Adverse event: Keratoacanthoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 74 at risk

Adverse event: Leukaemia
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 74 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 74 at risk

Adverse event: Cerebral microhaemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 74 at risk

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

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

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

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk

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

Adverse event: Device malfunction
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 74 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 74 at risk

Adverse event: Anxiety disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 74 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 74 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 74 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 74 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 74 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 74 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 74 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 74 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 74 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 74 at risk

Adverse event: Dyspnoea
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: 13 affected / 74 at risk

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

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 74 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Interstitial lung disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 74 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 74 at risk

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

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 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 embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 74 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

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

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

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

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

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

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 74 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 74 at risk

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

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

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

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

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

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 74 at risk

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

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 74 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 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: 4 affected / 74 at risk

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

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

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

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 74 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 74 at risk

Adverse event: Intermittent claudication
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 74 at risk

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

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 77 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 77 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 77 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 77 at risk

Adverse event: Contrast media allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Parainfluenzae virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 77 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 77 at risk

Adverse event: Radiation oesophagitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 77 at risk

Adverse event: Radiation pneumonitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 77 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 77 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 77 at risk

Adverse event: Transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 77 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 77 at risk

Adverse event: Immune-mediated lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 77 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 77 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 77 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 77 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 77 at risk

Adverse event: Pancytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 77 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 77 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 77 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 77 at risk

Adverse event: Supraventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 77 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 77 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 77 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 77 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 7 affected / 77 at risk

Adverse event: Hypopituitarism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 77 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 77 at risk

Adverse event: Thyroiditis
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 77 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 77 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 77 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 77 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 77 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 77 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 77 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 77 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 77 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 77 at risk

Adverse event: Odynophagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 77 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 77 at risk

Adverse event: Retching
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 77 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 77 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 77 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 77 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 77 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 77 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 77 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 77 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 6 affected / 77 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 77 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 77 at risk

Adverse event: Drug-induced liver injury
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 77 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Infectious pleural effusion
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Onychomycosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Oral fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Periodontitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 77 at risk

Adverse event: Post-acute COVID-19 syndrome
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 77 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 77 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 77 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 77 at risk

Adverse event: Fibula fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 77 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 77 at risk

Adverse event: Radiation fibrosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 77 at risk

Adverse event: Radiation fibrosis - lung
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 77 at risk

Adverse event: Radiation mucositis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 77 at risk

Adverse event: Radiation oesophagitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 77 at risk

Adverse event: Radiation pneumonitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 77 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 77 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 77 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 77 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 77 at risk

Adverse event: Anti-transglutaminase antibody increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 77 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 77 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 77 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 77 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 77 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 77 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 77 at risk

Adverse event: Blood thyroid stimulating hormone increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 77 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 77 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 77 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 77 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 77 at risk

Adverse event: Gastric pH decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 77 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 77 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 77 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 77 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 77 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 77 at risk

Adverse event: Protein total decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 77 at risk

Adverse event: Pulmonary function test decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 77 at risk

Adverse event: SARS-CoV-2 test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 77 at risk

Adverse event: Bile acids increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 77 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 77 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 77 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 29 affected / 77 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 77 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 77 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 77 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 77 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 77 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 77 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 77 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 77 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 77 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 77 at risk

Adverse event: Hypochloraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 77 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 77 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 77 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 77 at risk

Adverse event: Hypophagia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 77 at risk

Adverse event: Hypoproteinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 77 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 77 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 77 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 77 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 77 at risk

Adverse event: Cancer pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 77 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 77 at risk

Adverse event: Dizziness exertional
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 77 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 77 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 77 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 77 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 77 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 77 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 77 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 77 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 77 at risk

Adverse event: Erection increased
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 77 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Bronchitis chronic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 77 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 77 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 77 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 77 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 77 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 77 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 77 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 77 at risk

Adverse event: Pleurisy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 77 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 77 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 77 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 77 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 77 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 77 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pigmentation disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 77 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 77 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 77 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 77 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 77 at risk

Adverse event: Phlebitis superficial
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 77 at risk