Study: NCT03001882

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk

Adverse event: Thyroiditis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 31 at risk

Adverse event: Anal fissure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Autoimmune pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Autoimmune hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 31 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 31 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Brachial plexus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 31 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 31 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 31 at risk

Adverse event: Amylase increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 31 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 31 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 31 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 10 affected / 31 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Encephalitis autoimmune
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 31 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 31 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 31 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 31 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 31 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 31 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 31 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 31 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 31 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 31 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 31 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 31 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 31 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 31 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 31 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 31 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 31 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 31 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 31 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 31 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 31 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 31 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 31 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 31 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 31 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 31 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 31 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 31 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 31 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 31 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 31 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 31 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 31 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 31 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 31 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 31 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 31 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 31 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 31 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 31 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 31 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 31 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 31 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Empyema
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 28 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 28 at risk

Adverse event: Troponin I increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 28 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 28 at risk

Adverse event: Tumour ulceration
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 28 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Adnexa uteri mass
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Drug eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 28 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 28 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 28 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 28 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 28 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 28 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 28 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 28 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 28 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 28 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 28 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 28 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 28 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 28 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 28 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: Blood bicarbonate decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 28 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 28 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 28 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 28 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 28 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 28 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 28 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 28 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 28 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 28 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 28 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 28 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 28 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 28 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 28 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 28 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 28 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 28 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Peroneal nerve palsy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 28 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 28 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 28 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 28 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 28 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 28 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 28 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 28 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 28 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 28 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 28 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 28 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 28 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 28 at risk

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

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Nodal rhythm
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 170 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 170 at risk

Adverse event: Hypophysitis
Serious: yes
Organ System: Endocrine disorders
Frequency: 4 affected / 170 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 170 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Immune-mediated enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 170 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 170 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 170 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 170 at risk

Adverse event: Inflammation
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 170 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 170 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 170 at risk

Adverse event: Performance status decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 170 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 170 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 170 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 170 at risk

Adverse event: Drug-induced liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 170 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 170 at risk

Adverse event: Hepatitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 170 at risk

Adverse event: Hepatotoxicity
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 170 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Brain abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Klebsiella sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Oral fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 170 at risk

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 170 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 170 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 170 at risk

Adverse event: Depressed fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 170 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 170 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 170 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 170 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 170 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 170 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 170 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 170 at risk

Adverse event: General physical condition abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 170 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 170 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 170 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 170 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 170 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 170 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 170 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 170 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 170 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 170 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Myositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 170 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Cancer pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 170 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 38 affected / 170 at risk

Adverse event: Malignant pleural effusion
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 170 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 / 170 at risk

Adverse event: Neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 170 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 170 at risk

Adverse event: Phaeochromocytoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 170 at risk

Adverse event: Tumour associated fever
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 170 at risk

Adverse event: Tumour necrosis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 170 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Polyneuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 170 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 170 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 170 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 170 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 170 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 170 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Immune-mediated lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 170 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 170 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 170 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 170 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 170 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 37 affected / 170 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 170 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 16 affected / 170 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 15 affected / 170 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 170 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 170 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 170 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 170 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 65 affected / 170 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 170 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 170 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 170 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 170 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 170 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 170 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 170 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 170 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 170 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 9 affected / 170 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 43 affected / 170 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 170 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 4 affected / 170 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 170 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 18 affected / 170 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 27 affected / 170 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 170 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 170 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 170 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 170 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 170 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 170 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 170 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 30 affected / 170 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 29 affected / 170 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 33 affected / 170 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 170 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 170 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 170 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 28 affected / 170 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 170 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 170 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 170 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 38 affected / 170 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 170 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 170 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 170 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 170 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 170 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 170 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 170 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 170 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 170 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 170 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 170 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 170 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 170 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 170 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 170 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 170 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 170 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 170 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 170 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 170 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 170 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 170 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 170 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 170 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 170 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 170 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 170 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 170 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 45 affected / 170 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 45 affected / 170 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 170 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 170 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 170 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 170 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 170 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 170 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 170 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 170 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 170 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 170 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 43 affected / 170 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 42 affected / 170 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 170 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 170 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 170 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 170 at risk