Study: NCT01774721

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 227 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 227 at risk

Adverse event: Keratitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 227 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 227 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 227 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 227 at risk

Adverse event: Gastric ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 227 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 227 at risk

Adverse event: Mouth haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 227 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 227 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 227 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 227 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 227 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 227 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 227 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 227 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 227 at risk

Adverse event: Liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 227 at risk

Adverse event: Drug-induced liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 227 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 227 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 227 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 227 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 227 at risk

Adverse event: Bronchopulmonary aspergillosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 227 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 227 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 227 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 227 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 227 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 227 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 227 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 227 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 227 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 227 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 227 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 227 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 227 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 227 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 227 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 227 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 227 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 227 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 227 at risk

Adverse event: Chronic myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 227 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 227 at risk

Adverse event: Cerebral venous thrombosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 227 at risk

Adverse event: Spinal cord compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 227 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 227 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 227 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 227 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 227 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 227 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 227 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 227 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 227 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 227 at risk

Adverse event: Dermatitis acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 227 at risk

Adverse event: Drug eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 227 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 227 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 227 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 227 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 227 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 227 at risk

Adverse event: Ligament injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 227 at risk

Adverse event: Ligament rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 227 at risk

Adverse event: Metastases to meninges
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 227 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 227 at risk

Adverse event: Otitis media chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 227 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 227 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 199 affected / 227 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 99 affected / 227 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 227 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 227 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 227 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 227 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 227 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 227 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 227 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 227 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 227 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 32 affected / 227 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 19 affected / 227 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 26 affected / 227 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 21 affected / 227 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 227 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 13 affected / 227 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 16 affected / 227 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 140 affected / 227 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 227 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 227 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 227 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 227 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 227 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 67 affected / 227 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 53 affected / 227 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 49 affected / 227 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 227 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 227 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 227 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 227 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 227 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 73 affected / 227 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 227 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 227 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 227 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 227 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 227 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 227 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 227 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 227 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 227 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 32 affected / 227 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 47 affected / 227 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 227 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 227 at risk

Adverse event: Nasal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 227 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 227 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 227 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 112 affected / 227 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 64 affected / 227 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 53 affected / 227 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 47 affected / 227 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 41 affected / 227 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 227 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 227 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 227 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 227 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 227 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 227 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 227 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 227 at risk

Adverse event: Angular cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 227 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 227 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 227 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 227 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 227 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 227 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 224 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 224 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 224 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 224 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 224 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 224 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 224 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 224 at risk

Adverse event: Liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 224 at risk

Adverse event: Drug-induced liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 224 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 224 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 224 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 224 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 224 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 224 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 224 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 224 at risk

Adverse event: Extradural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 224 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 224 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 224 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 224 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 224 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 224 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 224 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 224 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 224 at risk

Adverse event: Polymyalgia rheumatica
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 224 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 224 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 224 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 224 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 224 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 224 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 224 at risk

Adverse event: Post herpetic neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 224 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 224 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 224 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 224 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 224 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 224 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 224 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 224 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 224 at risk

Adverse event: Organising pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 224 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 224 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 224 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 224 at risk

Adverse event: Cancer pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 224 at risk

Adverse event: Nervous system disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 224 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 224 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 125 affected / 224 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 224 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 224 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 224 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 224 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 224 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 224 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 224 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 224 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 224 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 224 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 30 affected / 224 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 27 affected / 224 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 20 affected / 224 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 8 affected / 224 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 224 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 7 affected / 224 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 224 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 224 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 224 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 224 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 224 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 224 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 224 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 43 affected / 224 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 90 affected / 224 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 84 affected / 224 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 224 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 224 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 224 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 224 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 224 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 58 affected / 224 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 224 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 224 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 224 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 37 affected / 224 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 224 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 224 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 224 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 224 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 224 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 33 affected / 224 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 224 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 224 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 224 at risk

Adverse event: Nasal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 224 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 224 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 224 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 64 affected / 224 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 224 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 224 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 224 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 224 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 224 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 224 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 224 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 224 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 224 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 224 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 224 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 224 at risk

Adverse event: Angular cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 224 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 224 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 224 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 224 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 224 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 224 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Ligament injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Ligament rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 11 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 11 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 11 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 11 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 11 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 11 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 11 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 11 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 11 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 11 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 11 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 11 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 11 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 11 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 11 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 11 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 11 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 11 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 11 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 11 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 11 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 11 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 11 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 11 at risk

Adverse event: Corneal erosion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Trichiasis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Chapped lips
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Glossodynia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Mass
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 11 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Immune system disorder
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 11 at risk

Adverse event: Nasal vestibulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 11 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 11 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Eosinophil count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Glomerular filtration rate decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Neutrophil count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Tetany
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Periarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vertebral artery stenosis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pelvic fluid collection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vulvovaginal rash
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Nasal mucosal ulcer
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Catarrh
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nasal mucosal disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hirsutism
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Papule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Ischaemia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk