Study: NCT03097328

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Vascular disorders - Other, specify
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 38 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 38 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Lymph node pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Atrioventricular block first degree
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 38 at risk

Adverse event: Cardiac disorders - Other, specify
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 38 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 38 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyperparathyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 38 at risk

Adverse event: Endocrine disorders - Other, specify
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 38 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Retinal detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 38 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 38 at risk

Adverse event: Small intestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 38 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 38 at risk

Adverse event: Small intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 38 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 38 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 24 affected / 38 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 38 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Bile duct stenosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nail infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 38 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 38 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 38 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 38 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 38 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 38 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 38 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 38 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 38 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 38 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Frequency: 1 affected / 38 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 38 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 38 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 38 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 38 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Metabolism and nutrition disorders - Other, specify
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Soft tissue necrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 38 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 38 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 38 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 38 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 38 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 38 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 38 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 38 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 38 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 38 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 38 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 38 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 38 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 38 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 38 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Urinary tract obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 38 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 38 at risk

Adverse event: Apnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 38 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 38 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pulmonary fibrosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 38 at risk

Adverse event: Tracheal fistula
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dermatitis bullous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 38 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 38 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Surgical and medical procedures - Other, specify
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 38 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 38 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 38 at risk

Adverse event: Vascular disorders - Other, specify
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 38 at risk