Study: NCT03133546

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Gastrointestinal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Gastric perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 76 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Overdose
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 76 at risk

Adverse event: Dermatitis acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 76 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 76 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: COVID-19 infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Enterocolitis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Hepatitis caused by COVID-19 infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Influenza A
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Pleural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Osteonecrosis of jaw
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 76 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 76 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 76 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 76 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 76 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 76 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 76 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 76 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 76 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 76 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 76 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 76 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 76 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 76 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 76 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 76 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 76 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 76 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 76 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 76 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 76 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 76 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 10 affected / 76 at risk

Adverse event: Ejection fraction decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 76 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 76 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 76 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 76 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 76 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 76 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 76 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 76 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 76 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 76 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 76 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 76 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 76 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 76 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 76 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 76 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 76 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 76 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 76 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 76 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 76 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 76 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 76 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 76 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 76 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 76 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 32 affected / 76 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 37 affected / 76 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 76 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 76 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 76 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 76 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 33 affected / 76 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 22 affected / 76 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 76 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 10 affected / 76 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 76 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 76 at risk

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

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

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 77 at risk

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

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

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

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

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

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

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

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

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

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

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

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

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 77 at risk

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

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

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 77 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 77 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 77 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric 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: Pleurodesis of malignant pleural effusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 77 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pelvic pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 77 at risk

Adverse event: Autoimmune disorder
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 77 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 77 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 77 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 77 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 77 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 77 at risk

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

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 77 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 77 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 77 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 77 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 77 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 77 at risk

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

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 5 affected / 77 at risk

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

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

Adverse event: Blood creatinine 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: 4 affected / 77 at risk

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 77 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 77 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 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: 5 affected / 77 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 77 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 77 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 77 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 77 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 77 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 77 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 77 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 77 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 77 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 77 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 77 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 77 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 77 at risk

Adverse event: Hyponatraemia
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: 6 affected / 77 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 77 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 77 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 77 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 77 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 77 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 77 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 29 affected / 77 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 77 at risk

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

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

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 77 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 77 at risk